TOTAL PROTEIN GEN.2
Received Aug 2, 2023 · Event occurred Jul 7, 2023
Report 1823260-2023-02500 · MDR key 17444082
Device
Generic name
Biuret Total Protein
Manufacturer
Roche DiagnosticsCatalog number
08058652190
Lot number
71320301
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Low Test Results
- No Apparent Adverse Event
- Incorrect, Inadequate or Imprecise Result or Readings
- Low Test Results
- No Apparent Adverse Event
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE INITIAL REPORTER RECEIVED A QUESTIONABLE TP2 TOTAL PROTEIN GEN.2 RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS PRO C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE INITIAL RESULT DID NOT MATCH TYPICAL RESULTS FOR THIS PATIENT AS THEY USUALLY RUN BETWEEN 6.7 AND 7.2 G/DL. THE INITIAL RESULT WAS 3.4 G/DL. THE REPORTER RERAN THE PATIENT SAMPLE 5 TIMES. THE REPEAT RESULT OF ALL 5 RERUNS WAS 6.6 G/DL. THE REPEAT RESULTS WERE DEEMED CORRECT.
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE CUSTOMER'S COBAS PRO C 503 ANALYTICAL UNIT IS (B)(6). THE INVESTIGATION IS ONGOING.
Additional Manufacturer Narrative
THE INVESTIGATION REVIEWED THE QC RECOVERY. THE RESULTS WERE WITHIN THE CUSTOMER¿S EXPECTED RANGES. THERE WAS NO INDICATION OF A PERFORMANCE ISSUE WITH THE REAGENT OR INSTRUMENT. THE INVESTIGATION REVIEWED THE ALARM TRACE. MULTIPLE ABNORMAL ASPIRATION SAMPLE PIPETTE ALARMS WERE PRESENT ON THE DATE OF THE EVENT. SAMPLE SHORT ALARMS WERE PRESENT AS WELL. THIS IS AN INDICATION OF POSSIBLE POOR SAMPLE QUALITY. THE INVESTIGATION COULD NOT DETERMINE THE EXACT CAUSE OF THE EVENT. THE INVESTIGATION DETERMINED THAT THE EVENT WAS CONSISTENT WITH A PREANALYTICAL ISSUE AT THE CUSTOMER SITE (ABNORMAL ASPIRATION AND SHORT SAMPLE ALARMS IN THE ALARM TRACE). BASED ON THE INFORMATION PROVIDED, THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.