MAUDE Adverse Event Report: ROCHE DIAGNOSTICS A-AMYLASE EPS VER. 2; AMYLASE TEST SYSTEM

Model Number	08056811190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
C503 analyzer a serial number is (b)(6).The customer's backup c503 analyzer b serial number was not provided.For c503 analyzer a: no issues were identified during a review of the reaction monitor data.Calibration was acceptable.Qc results were not stable and there were results outside of the acceptable range.Sample alarms were observed on the alarm trace data.Instrument checks passed.The investigation is ongoing.
Event or Problem Description
The initial reporter questioned high results not corresponding to the clinical picture for 1 patient tested for lipase colorimetric assay (lipc) and a-amylase eps ver.2 (amyl2) on 2 cobas c 503 analytical units.This medwatch will cover amyl2.Refer to medwatch with a1: patient identifier (b)(6) for information on the lipc results.On (b)(6) 2024 the initial lipc result from c503 analyzer a was 292 u/l.The amyl2 result was 161 u/l.On (b)(6) 2024 the patient was tested in a different laboratory using a cobas 6000 c501 module where the lipc result was 38 u/l and the amyl2 result was 86 u/l.These results were believed to be correct.On (b)(6) 2024 the original sample was repeated on the customer's backup c503 analyzer b and the lipc result was 279 u/l and the amyl2 result was 164 u/l.On (b)(6) 2024 a new sample was obtained and run on c503 analyzer a with a lipc result of 102 u/l and an amyl2 result of 124 u/l.
Additional Manufacturer Narrative
For c503 analyzer a: no further data or information can be provided as the instrument was damaged in a hurricane.Based on the information provided, the cause of the event could not be determined.The investigation did not identify a product problem.

• Brand Name: A-AMYLASE EPS VER. 2
• Common Device Name: AMYLASE 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: 19929735
• Report Number: 1823260-2024-02290
• Device Sequence Number: 2846961
• Product Code: JFJ
• UDI-Device Identifier: 07613336121009
• UDI-Public: 07613336121009
• Combination Product (Y/N): Y
• Initial Reporter Country: MX
• PMA/510(K) Number: K972250
• 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): 10/22/2024

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 Expiration Date: 03/31/2025
• Device Model Number: 08056811190
• Device Catalogue Number: 08056811190
• Device Lot Number: 78487101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/11/2024
• Supplement Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 10/22/2024
• 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
• Patient Age: 61 YR
• Patient Sex: Male