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	02/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1823260-2022-00787
• Device Sequence Number: 1545974
• Product Code: CHI
• UDI-Device Identifier: 04015630934812
• UDI-Public: 04015630934812
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 07041918190
• Device Lot Number: 584355
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2022
• Supplement Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 03/21/2022
• Supplement Report FDA Received Date: 05/20/2022
• 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 Sex: Unknown