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 02/24/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.

Event Description

The initial reporter received questionable lipc lipase colorimetric assay results for one patient tested on two cobas 8000 c (701) modules.It was unknown which cobas 8000 c (701) module was used for each lipase result.The customer provided the serial number of one cobas 8000 c (701) module, 19r1-07.On 24-feb-2022, the patient's initial lipase result was 202 u/l.Due to an internal laboratory rule, the sample was repeated on the same analyzer and the patient's lipase result was 201 u/l.The customer reported one of the patient's lipase results outside the laboratory.The patient's physician didn't trust the reported lipase results and requested a new sample to be tested.On 25-feb-2022, the patient went to a different laboratory and had a new sample collected.The patient's new sample had a lipase result of 36 u/l on an unknown methodology.The patient questioned the lipase results between the two laboratories.On 26-feb-2022, the customer performed repeat testing with the patient's initial sample on both cobas 8000 c (701) modules and had a lipase result of 203 u/l.The patient had a new sample collected and tested on the initial cobas 8000 c (701) module, and the patient's lipase result was 40 u/l.

Manufacturer Narrative

The investigation reviewed the customer's calibration and qc results and the results were acceptable.A general reagent issue could be excluded.The investigation reviewed the system alarm trace and found insufficient sample volume and abnormal sample aspiration alarms.Based on the provided information, 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13838947
• MDR Text Key: 292745491
• Report Number: 1823260-2022-00787
• Device Sequence Number: 1
• Product Code: CHI
• UDI-Device Identifier: 04015630934812
• UDI-Public: 04015630934812
• Combination Product (y/n): N
• 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
• Report Date: 05/20/2022

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 Catalogue Number: 07041918190
• Device Lot Number: 584355
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2022
• Initial Date FDA Received: 03/21/2022
• Supplement Dates Manufacturer Received: 04/28/2022
• Supplement Dates FDA Received: 05/20/2022
• 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