1823260-2017-01989

MDR report key: 6865751 · Received September 14, 2017

Report

Report Number: 1823260-2017-01989
Event Type: Malfunction
Date Received: September 14, 2017
Date of Event: August 23, 2017
Report Date: September 14, 2017
PMA / PMN Number: K961481
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: VM
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

(B)(4). (B)(6).

Description of Event or Problem · 1

THE CUSTOMER RECEIVED A QUESTIONABLE LOW ELECSYS HCG + BETA TEST SYSTEM RESULT FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 0.100 MIU/ML WITH A DATA FLAG AND WAS REPORTED OUTSIDE THE LABORATORY. AFTER A COMPLAINT WAS RECEIVED FROM THE CLINICAL DOCTOR, THE CUSTOMER REPEATED THE SAMPLE AND THE RESULT WAS 3402 MIU/ML. THIS RESULT WAS BELIEVED TO BE CORRECT. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE REAGENT LOT NUMBER WAS 210151 WITH AN EXPIRATION DATE OF 31-MAY-2018. A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED. THE CENTRIFUGATION CONDITIONS WERE FOUND TO NOT BE SUFFICIENT WHICH MAY HAVE LED TO AN ISSUE WITH SAMPLE QUALITY. THE ANALYZER ALARM DATA SHOWED A SAMPLE SHORT MESSAGE ON THE DAY OF THE EVENT WHICH MAY HAVE BEEN RELATED TO THIS SAMPLE. THEREFORE, A PREANALYTIC ISSUE WAS SUSPECTED. ANOTHER TYPICAL CAUSE FOR THIS TYPE OF EVENT IS INSUFFICIENT MAINTENANCE OF THE ANALYZER. REVIEW OF THE PROVIDED CALIBRATION AND QC DATA INDICATED A TREND OF LOW RECOVERIES. IT WAS NOTED CALIBRATION WAS CURRENTLY OVERDUE BY MORE THAN ONE MONTH PER THE RECOMMENDATION IN PRODUCT LABELING FOR THE ASSAY. A GENERAL REAGENT ISSUE WAS NOT A LIKELY CAUSE FOR EVENT. THE CUSTOMER WAS NOT USING THE RECOMMENDED SAMPLE TUBE RACK ADAPTERS.

Patients

Seq	Age	Sex	Outcome	Treatment
1