1823260-2017-01327

MDR report key: 6663379 · Received June 23, 2017

Report

Report Number: 1823260-2017-01327
Event Type: Malfunction
Date Received: June 23, 2017
Date of Event: June 6, 2017
Report Date: June 23, 2017
PMA / PMN Number: K100853
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: BR
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THIS EVENT OCCURRED IN (B)(6).

Description of Event or Problem · 1

THE CUSTOMER STATED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR THE ELECSYS HCG + BETA TEST SYSTEM (HCGB) ON A COBAS 8000 E 602 MODULE (E602). THE ERRONEOUS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED AS 0.298 MIU/ML. THE SAMPLE WAS REPEATED, RESULTING AS 204.7 MIU/ML ON (B)(6) 2017. THE SAMPLE WAS REPEATED A SECOND TIME, RESULTING AS 201.1 MIU/ML ON (B)(6) 2017. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE HCGB REAGENT LOT NUMBER WAS 210151. THE REAGENT EXPIRATION DATE WAS ASKED FOR, BUT NOT PROVIDED. UPON INVESTIGATION OF THE PROVIDED DATA, QUALITY CONTROLS ON THE DATE OF THE EVENT WERE WITHIN SPECIFIED LIMITS. DIFFERENT REAGENT KITS WERE USED TO MEASURE THE INITIAL LOW RESULT AND REPEAT RESULTS. A REVIEW OF THE ALARM TRACE REVEALED SEVERAL ABNORMAL SAMPLE ASPIRATION ALARMS ON THE DATE OF THE EVENT. A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. BASED ON THE ALARMS RECEIVED, THIS MAY BE AN INDICATION THAT THERE WAS AN ISSUE WITH LIQUID LEVEL DETECTION OF THE INSTRUMENT OR SAMPLE QUALITY.

Patients

Seq	Age	Sex	Outcome	Treatment
1	32 YR