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	04/02/2022
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 c (701) modules (serial numbers (b)(4)).The results of the sample did not agree with other clinical findings of the patient.The complained sample was initially tested on c701 serial number (b)(4), resulting in a lipase value of 239 u/l.The sample was repeated on the same analyzer due to an internal laboratory rule, resulting in a value of 239 u/l.The value was reported outside of the laboratory.The patient was prescribed a computed tomography scan based on the high value and a second sample collection was requested.A second sample was collected from the patient and tested twice on c701 serial number (b)(4) on (b)(6) 2022, resulting in lipase values of 37 u/l and 36 u/l.Both the complained sample and second sample were repeated.The complained sample was repeated on c701 serial number (b)(4), resulting in a lipase value of 220 u/l.The second sample was repeated on c701 serial number (b)(4), resulting in a value of 37 u/l.
Additional Manufacturer Narrative
A general reagent issue could be ruled out as calibration and controls are acceptable.No information was provided indicating the lipase assay is not working correctly.There was no evidence that drug metabolites in the patient's sample interfered with the lipase assay.The time span between the two sample collections of the patient fits with the biological half life of lipase.The investigation could not identify a product problem.

• 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: 14321900
• Report Number: 1823260-2022-01305
• Device Sequence Number: 5220039
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2022

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 Expiration Date: 04/30/2022
• Device Catalogue Number: 07041918190
• Device Lot Number: 58435501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2022
• Supplement Date Received by Manufacturer: 05/11/2022
• Initial Report FDA Received Date: 05/07/2022
• Supplement Report FDA Received Date: 06/06/2022
• 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 Age: 5 YR
• Patient Sex: Unknown