ALINITY I FREE T4 REAGENT KIT

Report

Report Number: 3005094123-2024-00602
Event Type: Malfunction
Date Received: November 20, 2024
Date of Event: September 2, 2024
Report Date: January 28, 2025
Manufacturer: ABBOTT IRELAND DIAGNOSTICS DIVISION
Product Code: CEC
UDI-DI: 00380740121822
PMA / PMN Number: K173122
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: KS
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. AN INCREASE IN COMPLAINTS HAS BEEN OBSERVED FOR LOT 60071UD00, HOWEVER, IN-HOUSE PERFORMANCE TESTING WAS COMPLETED WHICH INDICATES THE PRODUCT IS PERFORMING AS EXPECTED. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES, POTENTIAL NON-CONFORMANCES, OR DEVIATIONS ASSOCIATED WITH LOT 60071UD00 AND THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER¿S ISSUE. BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ALINITY I FREE T4 REAGENT FOR LOT 60071UD00 WAS IDENTIFIED.

Additional Manufacturer Narrative · 0

COMPLETE ENTRY FOR SECTION A1 - PATIENT IDENTIFIER: (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

Description of Event or Problem · 0

THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I FREE T4 FOR MULTIPLE PATIENTS. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE: FREE T4, 0.7 TO 1.48 NG/DL): ON (B)(6) 2024, SID (B)(6), INITIAL FT4 RESULT >5.00 NG/DL; REPEAT FT4 RESULT= 1.07 NG/DL, ON (B)(6) 2024, SID (B)(6), INITIAL FT4 RESULT 3.5 NG/DL; REPEAT FT4 RESULT= 1.02 NG/DL, ON (B)(6)2024, SID (B)(6), INITIAL FT4 RESULT >5.0 NG/DL; REPEAT FT4 RESULT= 1.1 NG/DL, ON (B)(6)2024, SID (B)(6), INITIAL FT4 RESULT= 2.14 NG/DL; REPEAT FT4 RESULT= 1.08 NG/DL, ON (B)(6)2024. SID (B)(6), INITIAL FT4 RESULT= 1.67 NG/DL; REPEAT FT4 RESULT= 1.31 NG/DL, ON (B)(6) 2024, SID (B)(6), INITIAL FT4 RESULT= 1.55 NG/DL; REPEAT FT4 RESULT= 1.26 NG/DL, ON (B)(6) 2024, SID (B)(6), INITIAL FT4 RESULT >5.00 NG/DL; REPEAT FT4 RESULT= 1.24 NG/DL, ON (B)(6) 2024, SID (B)(6), INITIAL FT4 RESULT= 1.64 NG/DL; REPEAT FT4 RESULT= 0.74 NG/DL, ON (B)(6) 2024, SID (B)(6), INITIAL FT4 RESULT= 1.54 NG/DL; REPEAT FT4 RESULT= 0.9 NG/DL, ON (B)(6) 2024, SID (B)(6), INITIAL FT4 RESULT= 1.54 NG/DL; REPEAT FT4 RESULT= 1.34 NG/DL, ON (B)(6) 2024, SID (B)(6), INITIAL FT4 RESULT= 1.56 NG/DL; REPEAT FT4 RESULT= 1.08 NG/DL, ON (B)(6) 2024, SID (B)(6), INITIAL FT4 RESULT= 2.23 NG/DL; REPEAT FT4 RESULT= 1.48 NG/DL, ON (B)(6) 2024, SID (B)(6), INITIAL FT4 RESULT >5.00 NG/DL; REPEAT FT4 RESULT= 0.89 NG/DL, ON (B)(6) 2024, SID (B)(6), INITIAL FT4 RESULT= 1.76 NG/DL; REPEAT FT4 RESULT= 0.94 NG/DL, ON (B)(6) 2024, SID (B)(6), INITIAL FT4 RESULT= 1.61 NG/DL; REPEAT FT4 RESULT= 1.32 NG/DL, ON (B)(6) 2024, SID (B)(6), INITIAL FT4 RESULT= 3.07 NG/DL; REPEAT FT4 RESULT= 1.03 NG/DL, ON (B)(6) 2024, SID (B)(6), INITIAL FT4 RESULT= 1.56 NG/DL; REPEAT FT4 RESULT= 1.16 NG/DL, ON (B)(6) 2024, SID (B)(6), INITIAL FT4 RESULT= 1.84 NG/DL; REPEAT FT4 RESULT= 0.6 NG/DL, ON (B)(6) 2024, SID (B)(6), INITIAL FT4 RESULT= 1.71 NG/DL; REPEAT FT4 RESULT= 1.05 NG/DL, ON (B)(6)2024, SID (B)(6), INITIAL FT4 RESULT >5.00 NG/DL; REPEAT FT4 RESULT= 1.14 NG/DL, ON (B)(6) 2024, SID (B)(6), INITIAL FT4 RESULT= 1.6 NG/DL; REPEAT FT4 RESULT= 1.34 NG/DL, ON (B)(6)2024, SID (B)(6), INITIAL FT4 RESULT= 1.62 NG/DL; REPEAT FT4 RESULT= 1.27 NG/DL, ON (B)(6)2024, SID (B)(6), INITIAL FT4 RESULT= 2.44 NG/DL; REPEAT FT4 RESULT= 0.92 NG/DL, ON (B)(6)2024, SID (B)(6), INITIAL FT4 RESULT >5.00 NG/DL; REPEAT FT4 RESULT= 0.87 NG/DL, ON (B)(6) 2024, SID (B)(6), INITIAL FT4 RESULT= 1.58 NG/DL; REPEAT FT4 RESULT= 0.9 NG/DL, ON (B)(6)2024, SID (B)(6), INITIAL FT4 RESULT= 1.53 NG/DL; REPEAT FT4 RESULT= 1.34 NG/DL, ON (B)(6)2024, SID (B)(6), INITIAL FT4 RESULT= 1.56 NG/DL; REPEAT FT4 RESULT= 0.99 NG/DL, ON (B)(6)2024, SID (B)(6), INITIAL FT4 RESULT >5.00 NG/DL; REPEAT FT4 RESULT= 1.08 NG/DL, ON (B)(6) 2024, SID (B)(6), INITIAL FT4 RESULT= 1.51 NG/DL; REPEAT FT4 RESULT= 1.13 NG/DL, ON (B)(6) 2024, SID (B)(6), INITIAL FT4 RESULT= 1.63 NG/DL; REPEAT FT4 RESULT= 1.15 NG/DL, ON (B)(6) 2024, SID (B)(6), INITIAL FT4 RESULT 1.81 NG/DL; REPEAT FT4 RESULT= 1.19 NG/DL, ON (B)(6)2024, SID (B)(6), INITIAL FT4 RESULT= 1.53 NG/DL; REPEAT FT4 RESULT= 1.21 NG/DL, ON (B)(6)2024, SID (B)(6), INITIAL FT4 RESULT= 1.65 NG/DL; REPEAT FT4 RESULT= 1.34 NG/DL, ON (B)(6)2024, SID (B)(6), INITIAL FT4 RESULT= 1.59 NG/DL; REPEAT FT4 RESULT= 0.9 NG/DL, ON (B)(6)2024, SID (B)(6), INITIAL FT4 RESULT= 1.77 NG/DL; REPEAT FT4 RESULT= 1.47 NG/DLON (B)(6)2024, SID (B)(6), INITIAL FT4 RESULT= 1.49 NG/DL; REPEAT FT4 RESULT= 1.03 NG/DL, ON (B)(6) 2024, SID (B)(6), INITIAL FT4 RESULT= 1.75 NG/DL; REPEAT FT4 RESULT= 1.06 NG/DL, ON (B)(6)2024, SID (B)(6), INITIAL FT4 RESULT= 1.6 NG/DL; REPEAT FT4 RESULT= 0.94 NG/DL, ON (B)(6) 2024, SID (B)(6), INITIAL FT4 RESULT= 1.95 NG/DL; REPEAT FT4 RESULT= 1.33 NG/DL . THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

Description of Event or Problem · 0

THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I FREE T4 FOR MULTIPLE PATIENTS. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE: FREE T4, 0.7 TO 1.48 NG/DL): (B)(6) 2024, SID (B)(6), INITIAL FT4 RESULT= 5.00 NG/DL; REPEAT FT4 RESULT= 1.07 NG/DL. (B)(6) 2024, SID (B)(6), INITIAL FT4 RESULT= 3.5 NG/DL; REPEAT FT4 RESULT= 1.02 NG/DL. (B)(6) 2024, SID (B)(6), INITIAL FT4 RESULT= 5.0 NG/DL; REPEAT FT4 RESULT= 1.1 NG/DL. (B)(6) 2024, SID (B)(6), INITIAL FT4 RESULT= 2.14 NG/DL; REPEAT FT4 RESULT= 1.08 NG/DL. (B)(6) 2024. SID (B)(6), INITIAL FT4 RESULT= 1.67 NG/DL; REPEAT FT4 RESULT= 1.31 NG/DL. (B)(6) 2024, SID (B)(6), INITIAL FT4 RESULT= 1.55 NG/DL; REPEAT FT4 RESULT= 1.26 NG/DL. (B)(6) 2024, SID (B)(6), INITIAL FT4 RESULT= 5.00 NG/DL; REPEAT FT4 RESULT= 1.24 NG/DL. (B)(6) 2024, SID (B)(6), INITIAL FT4 RESULT= 1.64 NG/DL; REPEAT FT4 RESULT= 0.74 NG/DL. (B)(6) 2024, SID (B)(6), INITIAL FT4 RESULT= 1.54 NG/DL; REPEAT FT4 RESULT= 0.9 NG/DL. (B)(6) 2024, SID (B)(6), INITIAL FT4 RESULT= 1.54 NG/DL; REPEAT FT4 RESULT= 1.34 NG/DL. (B)(6) 2024, SID (B)(6), INITIAL FT4 RESULT= 1.56 NG/DL; REPEAT FT4 RESULT= 1.08 NG/DL. (B)(6) 2024, SID (B)(6), INITIAL FT4 RESULT= 2.23 NG/DL; REPEAT FT4 RESULT= 1.48 NG/DL. (B)(6) 2024, SID (B)(6), INITIAL FT4 RESULT= 5.00 NG/DL; REPEAT FT4 RESULT= 0.89 NG/DL. (B)(6) 2024, SID (B)(6), INITIAL FT4 RESULT= 1.76 NG/DL; REPEAT FT4 RESULT= 0.94 NG/DL. (B)(6) 2024, SID (B)(6), INITIAL FT4 RESULT= 1.61 NG/DL; REPEAT FT4 RESULT= 1.32 NG/DL. (B)(6) 2024, SID (B)(6), INITIAL FT4 RESULT= 3.07 NG/DL; REPEAT FT4 RESULT= 1.03 NG/DL. (B)(6) 2024, SID (B)(6), INITIAL FT4 RESULT= 1.56 NG/DL; REPEAT FT4 RESULT= 1.16 NG/DL. (B)(6) 2024, SID (B)(6), INITIAL FT4 RESULT= 1.84 NG/DL; REPEAT FT4 RESULT= 0.6 NG/DL. (B)(6) 2024, SID (B)(6), INITIAL FT4 RESULT= 1.71 NG/DL; REPEAT FT4 RESULT= 1.05 NG/DL. (B)(6) 2024, SID (B)(6), INITIAL FT4 RESULT= 5.00 NG/DL; REPEAT FT4 RESULT= 1.14 NG/DL. (B)(6) 2024, SID (B)(6), INITIAL FT4 RESULT= 1.6 NG/DL; REPEAT FT4 RESULT= 1.34 NG/DL. (B)(6) 2024, SID (B)(6), INITIAL FT4 RESULT= 1.62 NG/DL; REPEAT FT4 RESULT= 1.27 NG/DL. (B)(6) 2024, SID (B)(6), INITIAL FT4 RESULT= 2.44 NG/DL; REPEAT FT4 RESULT= 0.92 NG/DL. (B)(6) 2024, SID (B)(6), INITIAL FT4 RESULT= 5.00 NG/DL; REPEAT FT4 RESULT= 0.87 NG/DL. (B)(6) 2024, SID (B)(6), INITIAL FT4 RESULT= 1.58 NG/DL; REPEAT FT4 RESULT= 0.9 NG/DL. (B)(6) 2024, SID (B)(6), INITIAL FT4 RESULT= 1.53 NG/DL; REPEAT FT4 RESULT= 1.34 NG/DL. (B)(6) 2024, SID (B)(6), INITIAL FT4 RESULT= 1.56 NG/DL; REPEAT FT4 RESULT= 0.99 NG/DL. (B)(6) 2024, SID (B)(6), INITIAL FT4 RESULT= 5.00 NG/DL; REPEAT FT4 RESULT= 1.08 NG/DL. (B)(6) 2024, SID (B)(6), INITIAL FT4 RESULT= 1.51 NG/DL; REPEAT FT4 RESULT= 1.13 NG/DL. (B)(6) 2024, SID (B)(6), INITIAL FT4 RESULT= 1.63 NG/DL; REPEAT FT4 RESULT= 1.15 NG/DL. (B)(6) 2024, SID (B)(6), INITIAL FT4 RESULT= 1.81 NG/DL: REPEAT FT4 RESULT= 1.19 NG/DL. (B)(6) 2024, SID (B)(6), INITIAL FT4 RESULT= 1.53 NG/DL; REPEAT FT4 RESULT= 1.21 NG/DL. (B)(6) 2024, SID (B)(6), INITIAL FT4 RESULT= 1.65 NG/DL; REPEAT FT4 RESULT= 1.34 NG/DL. (B)(6) 2024, SID (B)(6), INITIAL FT4 RESULT= 1.59 NG/DL; REPEAT FT4 RESULT= 0.9 NG/DL. (B)(6) 2024, SID (B)(6), INITIAL FT4 RESULT= 1.77 NG/DL; REPEAT FT4 RESULT= 1.47 NG/DL. (B)(6) 2024, SID (B)(6), INITIAL FT4 RESULT= 1.49 NG/DL; REPEAT FT4 RESULT= 1.03 NG/DL. (B)(6) 2024, SID (B)(6), INITIAL FT4 RESULT= 1.75 NG/DL; REPEAT FT4 RESULT= 1.06 NG/DL. (B)(6) 2024, SID (B)(6), INITIAL FT4 RESULT= 1.6 NG/DL; REPEAT FT4 RESULT= 0.94 NG/DL. (B)(6) 2024, SID (B)(6), INITIAL FT4 RESULT= 1.95 NG/DL; REPEAT FT4 RESULT= 1.33 NG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2460250	ALINITY I FREE T4 REAGENT KIT	RADIOIMMUNOASSAY, FREE THYROXINE	CEC	ABBOTT IRELAND DIAGNOSTICS DIVISION		60071UD00	00380740121822

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown		ALNTY I FREE T4 1200T, 07P70-30, 57607UD00\| ALNTY I FREE T4 1200T, 07P70-30, 57607UD00\| ALNTY I PROCESSING MODU, 03R65-01, (B)(6)\| ALNTY I PROCESSING MODU, 03R65-01, (B)(6)\| ALNTY I PROCESSING MODU, 03R65-01, (B)(6)\| ALNTY I PROCESSING MODU, 03R65-01,(B)(6)