MAUDE Adverse Event Report: ROCHE DIAGNOSTICS GAMMA-GLUTAMYLTRANSFERASE VER.2; GAMMA-GLUTAMYL TRANSPEPTIDASE AND ISOENZYMES TEST SYSTEM

Catalog Number	03002721122
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The calibration results from (b)(6) 2024 and (b)(6) 2024 were acceptable.The qc recoveries were within the +/-2 standard deviation range.The alarm trace did not contain a conspicuous event.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable ggt-2 ¿-glutamyltransferase ver.2 standardized against ifcc / szasz results for 1 patient sample on a cobas 6000 c501 module.The initial ggt-2 result was 4 u/l.The sample was repeated and the result was 26 u/l.The repeat result was deemed correct.
Additional Manufacturer Narrative
The alarm trace showed several sample short and abnormal probe sucking alarms.It was found that the customer does not clean the analyzer sample and reagent probes daily as instructed in the operator's manual.Based on the calibration and qc data, a general reagent issue could be excluded.The root cause of the event was found to be consistent with pre-analytical sample handling issues.The investigation did not identify a product problem.

• Brand Name: GAMMA-GLUTAMYLTRANSFERASE VER.2
• Common Device Name: GAMMA-GLUTAMYL TRANSPEPTIDASE AND ISOENZYMES TEST SYSTEM
• 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: 20384249
• Report Number: 1823260-2024-02900
• Device Sequence Number: 20835247
• Product Code: JQB
• UDI-Device Identifier: 04015630916511
• UDI-Public: 04015630916511
• Combination Product (Y/N): Y
• Initial Reporter Country: TU
• PMA/510(K) Number: K951595
• 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): 11/20/2024

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: 10/31/2024
• Device Catalogue Number: 03002721122
• Device Lot Number: 77885901
• 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: 09/13/2024
• Supplement Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 10/07/2024
• Supplement Report FDA Received Date: 11/20/2024
• 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