FDA Adverse Event Malfunction Summary report: N

REFLOTRON POTASSIUM TEST TABS

MDR report key: 1670044 · Received April 29, 2010

Report

Report Number: 1823260-2010-02553
Event Type: Malfunction
Date Received: April 29, 2010
Date of Event: April 6, 2010
Report Date: June 9, 2010
Product Code: CEJ
PMA / PMN Number: K904033
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CH
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

EXPIRATION DATE OF REFLOTRON POTASSIUM TEST TABS WAS NOT PROVIDED. IT IS UNKNOWN IF INITIAL REPORTER SENT REPORT TO FDA.

Additional Manufacturer Narrative · 1

DIFFERENCES BETWEEN PLASMA AND SERUM POTASSIUM VALUES, WHICH EXCEEDED 0.8 MMOL/L, COULD NOT BE VERIFIED. NO MALFUCTION WAS DETECTED. BOTH OF THE PATIENT'S POTASSIUM VALUES WERE BELOW THE RESPECTIVE REFERENCE RANGES FOR THE SAMPLE MATERIAL. A POTASSIUM SUBSTITUTION WOULD HAVE BEEN CONSIDERED WITH EITHER VALUE.

Description of Event or Problem · 1

COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE FAILED TO DISCHARGE. COMPLAINANT INDICATED THAT THERE WAS NO PT INVOLVEMENT IN THE REPORTED MALFUNCTION.

Description of Event or Problem · 1

CUSTOMER HAD A HEPARIN PLASMA SAMPLE AND A SERUM SAMPLE DRAWN AT THE SAME TIME FROM ONE PATIENT. THE POTASSIUM RESULTS FROM THE TWO SAMPLES WERE DISCREPANT. PLASMA SAMPLE POTASSIUM RESULTS WERE 2.79 AND 2.86, NO UNITS OF MEASURE PROVIDED. SERUM SAMPLE POTASSIUM RESULTS WERE 3.58 AND 3.50, NO UNITS OF MEASURE PROVIDED. NO INFORMATION WAS PROVIDED TO DETERMINE WHICH RESULTS WERE REPORTED OR IF PATIENT WAS AFFECTED. NO ADVERSE EVENTS WERE REPORTED. POTASSIUM REAGENT LOT WAS 23761233. INVESTIGATION IS ON-GOING.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	REFLOTRON POTASSIUM TEST TABS	POTASSIUM TEST SYSTEM	CEJ		NA	23761230

Patients

Seq	Age	Sex	Outcome	Treatment
1