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

Catalog Number	08057982190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received questionable results for one patient sample tested with lipc (lipase) on a cobas pro c 503 analytical unit.On (b)(6) 2023, a first sample collected from the patient resulted in a lipase value of 25 u/l.On (b)(6) 2023, a second sample was collected from the patient and resulted in a lipase value of 698 u/l.On (b)(6) 2023, a third sample was collected from the patient and resulted in a lipase value of 22 u/l.The result from the second sample was questioned as an increase of 698 u/l would not be expected based on the lower results received on (b)(6) 2023 and (b)(6) 2023.The second sample was repeated, resulting in a lipase value of 713 u/l.This sample was also repeated on a second analyzer, resulting in a lipase value of 768 u/l.
Additional Manufacturer Narrative
The serial number of the cobas pro c 503 analytical unit is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
Calibration and controls recovered within specifications.A sample from the patient was provided for investigation and the result obtained by the customer could be reproduced.In the absence of detailed information about the patient, including diagnosis and medical history, no definitive assessment could be made as to the cause of the elevated results.Based on the immunoglobulin results of the sample obtained during the investigation an interference due to gammopathy can be ruled out.In rare cases, gullo syndrome: benign pancreatic hyperenzymemia, could be present.This is an identified syndrome characterized by an abnormal increase in serum pancreatic enzymes in the absence of pancreatic disease.Strong fluctuations within a very short time are possible.

• 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: 17612027
• Report Number: 1823260-2023-02752
• Device Sequence Number: 15303564
• Product Code: CHI
• UDI-Device Identifier: 07613336121399
• UDI-Public: 07613336121399
• 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): 10/09/2023

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 Catalogue Number: 08057982190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/28/2023
• Supplement Date Received by Manufacturer: 10/06/2023
• Initial Report FDA Received Date: 08/24/2023
• Supplement Report FDA Received Date: 10/09/2023
• 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: ACUPAN (INTRAVENOUS); AUGMENTIN (INTRAVENOUS); AUGMENTIN (ORAL); ENERGY DRINK; IBUPROFEN; IZALGI (ORAL); PARACETAMOL (ORAL)
• Patient Sex: Unknown