FDA Adverse Event Malfunction Summary report: N

2050010-2017-00001

MDR report key: 6948249 · Received October 13, 2017

Report

Report Number: 2050010-2017-00001
Event Type: Malfunction
Date Received: October 13, 2017
Date of Event: September 25, 2017
Report Date: October 9, 2017
PMA / PMN Number: K902801
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: EZ
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THE CUSTOMER INFORMED CUSTOMER TECHNICAL SUPPORT (CTS) THAT A REPLACEMENT OF THE TBIL REAGENT WITH A DIFFERENT LOT RESOLVED THE ISSUE.

Description of Event or Problem · 1

THE CUSTOMER REPORTED OBTAINING FALSE LOW TOTAL BILIRUBIN (TBIL) RESULTS, FOR AN UNKNOWN NUMBER OF PATIENT SAMPLES, INVOLVING THE UNICEL DXC 860I SYNCHRON ACCESS CLINICAL SYSTEM. THE FALSE LOW TOTAL BILIRUBIN RESULTS WERE GENERATED USING TBIL REAGENT, LOT M703066. THE FALSE LOW TBIL RESULTS WERE REPORTED OUTSIDE THE LABORATORY AND WERE QUESTIONED BY THE PHYSICIAN. THE CUSTOMER INDICATED THE PROBLEM WAS REGARDING TBIL SAMPLES WITH CONCENTRATIONS < 10 UMOL/L. THE INITIAL TBIL RESULTS WERE RECOVERING APPROXIMATELY 1.5 - 2 UMOL/L AND THE REPEAT RESULTS WERE RECOVERING 2-3 TIMES HIGHER. THE CUSTOMER REPEATED THE PATIENT SAMPLES USING A DIFFERENT LOT OF TBIL REAGENT, LOT M705026 AND THE RESULTS WERE HIGHER WHICH WERE CONSIDERED CORRECT BY THE CUSTOMER. (NOTE: THE CUSTOMER RECEIVED TBIL REAGENT LOT M705026 ON A SEPARATE SHIPMENT FROM LOT M703066) IT IS UNKNOWN IF THERE WAS A CHANGE TO PATIENT TREATMENT CONNECTED TO THIS EVENT. THE CUSTOMER WAS USING BIO-RAD LYPHOCHEK ASSAYED CHEMISTRY CONTROL, LEVELS 1 (LOT 26411) AND LEVEL 2 (LOT 26412) AT THE TIME OF THE EVENT. QUALITY CONTROL FOR TBIL WAS RECOVERING CLOSE TO THE TARGET ASSIGNED MEAN VALUE FOR EACH LEVEL OF CONTROL.

Patients

Seq	Age	Sex	Outcome	Treatment
1