MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CREP2; CREATININE TEST SYSTEM

Model Number	CREP G2
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation of discrepant results for 2 samples from the same patient tested creatinine (crep2) assay on a cobas pro c 503 analytical unit serial number (b)(4).On (b)(6) 2023 the cusomer ran the patient's samples and received the following crep2 results: sample 1: the initial result was 136 mol/l.The first repeated result was 65.8 mol/l.The second repeated result was 66 mol/l.The third repeated result, on a different instrument, the result was 66 mol/l.Sample 2: the initial result was 203 mol/l.The first repeated result was 66 mol/l.The second repeated result was 66 mol/l.The third repeated result, on a different instrument, the result was 66 mol/l.The patient was admitted to the emergency room due to a chest pain and she was treated with an nacl infusion.And the above tests were performed.Calibration and qc were within specifications.
Additional Manufacturer Narrative
Since the calibration and qc were within specifications, a general issue can be excluded.Investigation is ongoing.
Additional Manufacturer Narrative
The patient had a transfusion.An interference of a drug can be excluded, as the reruns out of the same samples were lower.The alarm trace showed several abnormal aspiration alarms and abnormal cell blank.The investigation did not identify a product problem.The investigation determined the root cause of the issue was consistent with a pre-analytical handling issue.

• Brand Name: CREP2
• Common Device Name: CREATININE TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16584855
• Report Number: 1823260-2023-00917
• Device Sequence Number: 19254517
• Product Code: JFY
• UDI-Device Identifier: 07613336121160
• UDI-Public: 07613336121160
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K812095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: CREP G2
• Device Catalogue Number: 08057524190
• Device Lot Number: 69245901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2023
• Supplement Date Received by Manufacturer: 04/17/2023
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 05/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NACL INFUSION ONCE.
• Patient Sex: Unknown