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

Catalog Number	07041918190
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Na.
Event or Problem Description
The initial reporter stated they received questionable results for one patient sample tested with the lipc (lipase colorimetric) assay on two cobas 8000 c702 modules (serial numbers (b)(4).The results of the sample did not agree with other clinical findings of the patient.On (b)(6) 2022, the sample was initially tested on c702 serial number (b)(4), resulting in an lipc value of 738.4 u/l, accompanied by a data flag.The sample was repeated with a reduced volume, resulting in an lipc value of 900.3 u/l.Based on this result, the patient was hospitalized again.On (b)(6) 2022, a sample of the patient was tested in the hospital with an unknown method, resulting in a lipase value of 97.No unit of measure was provided.On (b)(6) 2022, the sample from (b)(6) 2022 was repeated on c702 serial number (b)(4), resulting in an lipc value of 758.4 u/l, accompanied by a data flag.The sample was repeated with a reduced volume, resulting in an lipc value of 927.8 u/l.The result of (b)(6) 2022 was deemed to be "too high" and clinically not possible.The questionable result was reported outside of the laboratory.
Additional Manufacturer Narrative
Calibration results were acceptable.Quality controls were within specification.Interference with respect to the patient's acetaminophen or fluvermal medication can be excluded.Based on the available data, a general reagent issue can be excluded.The investigation could 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16003761
• Report Number: 1823260-2022-04071
• Device Sequence Number: 20502836
• 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): 02/17/2023

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: 12/31/2022
• Device Catalogue Number: 07041918190
• Device Lot Number: 647171
• 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: 11/25/2022
• Supplement Date Received by Manufacturer: 01/20/2023
• Initial Report FDA Received Date: 12/19/2022
• Supplement Report FDA Received Date: 02/17/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ACETAMONIPHEN; FLUVERMAL
• Patient Age: 12 YR
• Patient Sex: Male