1823260-2017-02190

MDR report key: 6912043 · Received October 3, 2017

Report

Report Number: 1823260-2017-02190
Event Type: Malfunction
Date Received: October 3, 2017
Date of Event: September 15, 2017
Report Date: October 3, 2017
PMA / PMN Number: K100853
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

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

Description of Event or Problem · 1

THE CUSTOMER REPORTED QUESTIONABLE CALCIUM RESULTS FOR AN UNKNOWN NUMBER OF PATIENT SAMPLES OUTSIDE OF THE LABORATORY. THE RESULTS WERE QUESTIONED BY THE DOCTOR AND APPROXIMATELY FIVE SAMPLES IN QUESTIONED WERE REPEATED. DATA WAS PROVIDED FOR FOUR PATIENT SAMPLES. PATIENT 1 INITIAL RESULT WAS 1.94 MMOL/L AND THE REPEAT RESULT WAS 2.35 MMOL/L. PATIENT 2 INITIAL RESULT WAS 1.92 MMOL/L AND THE REPEAT RESULT WAS 2.31 MMOL/L. PATIENT 3 INITIAL RESULT WAS 1.91 MMOL/L AND THE REPEAT RESULT WAS 2.48 MMOL/L. PATIENT 4 INITIAL RESULT WAS 1.83 MMOL/L AND THE REPEAT RESULT WAS 2.30 MMOL/L. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE REAGENT LOT NUMBER WAS 221425. THE EXPIRATION DATE WAS REQUESTED BUT WAS NOT PROVIDED. NO RESULTS FOR OTHER ASSAYS WERE AFFECTED. THE FIELD SERVICE REPRESENTATIVE NOTICED THE WASH NOZZLE ON THE RINSE STATION WAS DRIPPING BACK INTO THE CUVETTES. HE FOUND THE VACUUM DIAPHRAGMS WERE OLD AND ONE WAS SLIGHTLY SPLIT CAUSING A VACUUM ABNORMALITY. THE VALVES WERE CLEANED AND THE DIAPHRAGMS REPLACED. THE RINSE STATION TUBING WAS INSPECTED, BUT NO DAMAGE WAS FOUND. THE CALIBRATION AND QC DATA PROVIDED DID NOT INDICATE A REAGENT ISSUE. FURTHER INVESTIGATION DETERMINED THE ROOT CAUSE WAS TOO LITTLE SAMPLE VOLUME IN THE REACTION DUE TO A SAMPLE QUALITY ISSUE OR MOST LIKELY DUE TO DILUTION IN THE CUVETTE CAUSED BY THE ISSUES FOUND BY THE FIELD SERVICE REPRESENTATIVE.

Patients

Seq	Age	Sex	Outcome	Treatment
1