MAUDE Adverse Event Report: ROCHE DIAGNOSTICS GAMMA-GLUTAMYLTRANSFERASE (GGT); GAMMA-GLUTAMYL TRANSPEPTIDASE

Catalog Number	08057796190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
C503 analyzer a serial number was (b)(6).The serial number for c503 analyzer b was not provided.
Event or Problem Description
The initial reporter complained of discrepant results for 1 patient sample tested for gamma-glutamyltransferase (ggt) on two cobas c 503 analytical units.The initial result was 91.4 ui/l on c503 analyzer a.The sample was repeated on c503 analyzer a with results of 55.6 ui/l, 57 ui/l, and 66 ui/l.The sample was repeated on c503 analyzer b with a result of 91.4 ui/l accompanied by an invalidating data flag.The repeat results on c503 analyzer b were 91.4 ui/l and 56 ui/l.The results close to 56 ui/l were believed to be correct.Another sample from the patient was repeated 5 times with results of 51 ui/l and 52 ui/l.
Additional Manufacturer Narrative
Calibration was acceptable.The customer stated qc was acceptable.Multiple "abnormal aspiration" and "sample short" alarms were observed on the alarm trace data.The analyzer was inspected and crystallization of basic wash solution was observed around a manifold (likely from a previous leak in (b)(6) 2024; no current leaks were observed).Sample and reagent probes were replaced and adjusted, and the ultrasonic mixer height and water supply were adjusted.Instrument performance testing was acceptable.The specific cause of the event could not be determined; however, the investigation determined the event was consistent with a preanalytical handling issue.

• Brand Name: GAMMA-GLUTAMYLTRANSFERASE (GGT)
• Common Device Name: GAMMA-GLUTAMYL TRANSPEPTIDASE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 19819604
• Report Number: 1823260-2024-02146
• Device Sequence Number: 8728151
• Product Code: JQB
• UDI-Device Identifier: 07613336121252
• UDI-Public: 07613336121252
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• PMA/510(K) Number: K972250
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2024

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: 01/31/2025
• Device Catalogue Number: 08057796190
• Device Lot Number: 794275
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/03/2024
• Supplement Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 12/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown