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	05/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the cobas 8000 c702 module is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter received a questionable lipc lipase colorimetric (lipc) result for one patient sample tested on a cobas 8000 c702 module.The reporter suspects drug interference.On (b)(6) 2024: at 7:00 am, the patient took the following oral medications: kestin - 1 teaspoon; bilaska 1 teaspoon; selexid - 2 tablets; ultra yeast - 1 capsule; st.John's wort -1 teaspoon; santarom - 1 teaspoon; and gyndelta - 1 capsule.At 7:50 am, the patient's first blood sample was collected.The initial result of the first sample from the module was >666.40 u/l.The repeat result of the first sample from the module was 831 u/l with a data flag.The first sample was rerun on two other cobas c702s and the results were still close to 800 u/l.On (b)(6) 2024: the patient did not take any medications.The initial result of the second sample from the module was 34 u/l.The repeat result of the second sample from the module was 35 u/l.
Additional Manufacturer Narrative
The investigation reviewed the lipc calibration traces from aug-2021 to feb-2024.The calibration on 07-may-2024 had errors but the qc was within the +2 standard deviation range.The investigation reviewed the qc.The qc was stable and within +/- 2 standard deviation range since jan-2024.The investigation reviewed the alarm trace.The trace on (b)(6) 2024 had abnormal aspiration alarms close to the initial run of the patient sample.The instrument data showed four to eight abnormal sample aspiration alarms.The investigation determined the event can be explained by different physiological processes such as interval of patient sample collection, results physiologically compatible with life, normalization after correction of an obstruction, diseases other than pancreatitis that could also increase lipase, some antibiotics which can increase physiological activity without pancreatitis, or a syndrome which triggers fast-changing lipase levels without any concrete pathological function.There is no indication of a medication-induced assay malfunction.The investigation did 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 19587691
• Report Number: 1823260-2024-01837
• Device Sequence Number: 15245598
• Product Code: CHI
• UDI-Device Identifier: 04015630934812
• UDI-Public: 04015630934812
• Combination Product (Y/N): Y
• 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): 08/16/2024

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: 782054
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/31/2024
• Supplement Date Received by Manufacturer: 08/01/2024
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: BILASKA; CRANBERRY; KESTIN; SANTAROME; SELEXID; ST. JOHN'S WORT; ULTRA YEAST
• Patient Age: 28 YR
• Patient Sex: Female