FDA Adverse Event Malfunction Summary report: N

ARCHITECT TOTAL PSA

MDR report key: 10513454 · Received September 10, 2020

Report

Report Number: 3008344661-2020-00068
Event Type: Malfunction
Date Received: September 10, 2020
Date of Event: August 19, 2020
Report Date: October 22, 2020
Manufacturer: ABBOTT IRELAND DIAGNOSTICS DIVISION
Product Code: LTJ
PMA / PMN Number: P910007
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FI
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 0

AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM ARCHITECT TOTAL PSA LIST 7K70-35, MANUFACTURING SITE ABBOTT IRELAND DIAGNOSTICS DIVISION, SLIGO TO THE ARCHITECT I2000SR INSTRUMENT LIST 03M74-02 MANUFACTURING SITE ABBOTT LABORATORIES IRVING, TEXAS. MDR NUMBER 3016438761-2020-00253-00 HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER.

Additional Manufacturer Narrative · 1

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THERE WAS NO FURTHER PATIENT INFORMATION PROVIDED BY THE CUSTOMER. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7K70 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 6C06.

Description of Event or Problem · 1

THE CUSTOMER REPORTED FALSELY DEPRESSED ARCHITECT TOTAL PSA RESULTS ON ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) GENERATED A RESULT OF < 0.01 UG/L. TWO WEEKS EARLIER THE SAME PATIENT SID (B)(6) GENERATED A RESULT OF 1.085 UG/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
981927	ARCHITECT TOTAL PSA	TOTAL PSA	LTJ	ABBOTT IRELAND DIAGNOSTICS DIVISION		09517FN00

Patients

Seq	Age	Sex	Outcome	Treatment
1				ARC I2000SR INST, 03M74-02, (B)(6) \| ARCHITECT I2000SR ANALYZER, LIST 03M74-02,\| SERIAL (B)(6)