FDA Adverse Event Malfunction Summary report: N

1823260-2017-01690

MDR report key: 6792583 · Received August 14, 2017

Report

Report Number: 1823260-2017-01690
Event Type: Malfunction
Date Received: August 14, 2017
Date of Event: July 4, 2017
Report Date: September 13, 2017
PMA / PMN Number: K961481
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: BR
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

ALL THE INITIAL AND REPEAT HCG + B RESULTS FROM THE EVENT WERE ACCOMPANIED BY DATA FLAGS. THE INITIAL RESULT OF 4.45 MIU/ML WITH A DATA FLAG WAS REPEATED BECAUSE IT WAS WITHIN THE LABORATORY'S REPEAT RANGE.

Additional Manufacturer Narrative · 1

A SPECIFIC ROOT CAUSE WAS NOT IDENTIFIED. QUALITY CONTROL RESULTS DO NOT INDICATE AN ISSUE. LIQUID FLOW CLEANING IS PERFORMED WEEKLY. THE MEASURING CELL COUNT ON (B)(6) 2017 WAS 26613. NO ISSUES WERE IDENTIFIED DURING A REVIEW OF THE ALARM TRACE. POSSIBLE ROOT CAUSES FOR THIS EVENT MAY BE SAMPLE QUALITY AND INSUFFICIENT MAINTENANCE.

Additional Manufacturer Narrative · 1

THIS EVENT OCCURRED IN (B)(6).(B)(4).

Description of Event or Problem · 1

THE CUSTOMER COMPLAINED OF AN ERRONEOUS LOW RESULT FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS HCG + BETA TEST SYSTEM (HCG + B) ON A COBAS E 411 IMMUNOASSAY ANALYZER. THE ERRONEOUS RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE INITIAL HCG + B RESULT WAS 4.45 MIU/ML. THE SAMPLE WAS REPEATED 2 MORE TIMES ON THE DAY OF THE EVENT AND THE RESULTS WERE 938.1 MIU/ML AND 908.9 MIU/ML. ON (B)(6) 2017 THE SAMPLE WAS REPEATED 4 MORE TIMES WITH RESULTS OF 949.2 MIU/ML, 970.8 MIU/ML, 934.3 MIU/ML AND 964.0 MIU/ML. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE HCG + B REAGENT LOT NUMBER WAS 210151. THE EXPIRATION DATE WAS NOT PROVIDED.

Patients

Seq	Age	Sex	Outcome	Treatment
1	39 YR