MAUDE Adverse Event Report: ROCHE DIAGNOSTICS LIPC; LIPASE TEST SYSTEM

Catalog Number	07041918190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The c701 module serial number was (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter complained of discrepant results for 1 patient sample tested for lipc lipase colorimetric (lipc) on a cobas 8000 c (701) module.Data was provided with discrepant results for an additional patient sample (patient 2).On (b)(6) 2023 patient 2 initial result was greater than 410.6 u/l.The repeat result using dilution was 478 u/l.On (b)(6) 2023 the repeat result was 37 u/l.On (b)(6) 2023 patient 1 initial result was 700 u/l.The sample was repeated on (b)(6) 2023 with a result of 40 u/l.
Additional Manufacturer Narrative
The initial report stated: "on (b)(6) 2023 patient 2 initial result was greater than 410.6 u/l.The repeat result using dilution was 478 u/l.On (b)(6) 2023 the repeat result was 37 u/l." it was clarified that the repeat result using dilution was 477.7 u/l.It was clarified that the result from (b)(6) 2023 was from a new sample and the result was 37.3 u/l.Sections a2 and a3 were updated.Section d4, lot number and expiration date were updated.
Additional Manufacturer Narrative
Section d4, lot number was updated.Calibration was last performed on (b)(6) 2023 and was acceptable.Qc was acceptable.The customer had no issues with other patient samples or other assays.The customer regularly cleans the sample and reagent probes.All necessary special wash programming has been installed.The photometer lamp and cuvettes have been replaced according to recommendations.No changes were made to the gear pump.The customer has not complained of further issues.A general reagent problem was excluded as calibration and qc were acceptable.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: LIPC
• Common Device Name: LIPASE 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: 17613940
• Report Number: 1823260-2023-02763
• Device Sequence Number: 17822286
• Product Code: CHI
• UDI-Device Identifier: 04015630934812
• UDI-Public: 04015630934812
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• 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,Followup
• Report Date (Section B): 11/20/2023

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: 10/31/2023
• Device Catalogue Number: 07041918190
• Device Lot Number: 728305
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/31/2023
• Supplement Date Received by Manufacturer: 08/24/2023; 11/07/2023
• Initial Report FDA Received Date: 08/24/2023
• Supplement Report FDA Received Date: 09/07/2023; 11/20/2023
• 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
• Patient Age: 23 YR
• Patient Sex: Male