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

Catalog Number	07041918190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Last calibration performed on (b)(6) 2022 quality control results between (b)(6) 2022 were within specification.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for one patient tested with lipc (lipase colorimetric) on a cobas 8000 c702 module with serial no.1944-10.The results measured on the c702 module did not compare to the results obtained with the beckman coulter method and to the expected values based on the clinical history of the patient.On (b)(6) 2022, the initial sample, collected at 6.15 am resulted in a value of 558 u/l.On (b)(6) 2022, a second sample from the same patient, collected at 12 am resulted in a value of 77 u/l, tested with the beckman coulter method.On (b)(6) 2022, a third sample from the same patient, collected at 9.20 am resulted in a value of 362 u/l.On (b)(6) 2022, a fourth sample from the same patient, collected at 12:04 pm resulted in a value of 110 u/l, tested with the beckman coulter method.On (b)(6) 2022, a fifth sample from the same patient, collected at 5.20 pm on (b)(6) 2022 resulted in a value of 92.4 u/l.
Additional Manufacturer Narrative
On 28-nov-2022, the customer retested the sample from (b)(6) 2022, collected at 9.20 am with a beckman coulter method, resulting in a value of 287 u/l.The investigation is ongoing.
Additional Manufacturer Narrative
Medwatch field d10 has been updated.
Additional Manufacturer Narrative
Based on the information provided a general reagent issue can be excluded.Drug interferences have been excluded.Doliprane (acetaminophen) is part of the tested drug panel and interference was not detected.Per product labeling: "no interference was found at therapeutic concentrations using common drug panels." based on the too-low dosage of eurobiol (pancreatin) an influence on the serum values was 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: 15696413
• Report Number: 1823260-2022-03422
• Device Sequence Number: 17848034
• 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,Followup,Followup
• Report Date (Section B): 02/28/2023

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: 64717101
• 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: 10/07/2022
• Supplement Date Received by Manufacturer: 11/28/2022; 12/21/2022; 02/01/2023
• Initial Report FDA Received Date: 10/29/2022
• Supplement Report FDA Received Date: 12/16/2022; 01/13/2023; 02/28/2023
• 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: BISOPROLOL 1,25.; DOLIPRANE.; EUROBIOL 6/J.; IRBESARTAN 150.; LEVOTHYROX 100.; ULTIBRO BREEZHALER (INHALATION BATH).; XANAX 3/J.
• Patient Age: 60 YR
• Patient Sex: Female