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

Catalog Number 07041918190

Device Problem Non Reproducible Results (4029)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/26/2023

Event Type  malfunction  

Manufacturer Narrative

The c701 module serial number was (b)(6).The investigation is ongoing.

Event 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.

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.

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
• Type of Device: 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
• MDR Text Key: 322483271
• Report Number: 1823260-2023-02763
• Device Sequence Number: 1
• Product Code: CHI
• Combination Product (y/n): Y
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 07/31/2023
• Initial Date FDA Received: 08/24/2023
• Supplement Dates Manufacturer Received: 08/24/2023; 11/07/2023
• Supplement Dates FDA Received: 09/07/2023; 11/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 23 YR
• Patient Sex: Male