MAUDE Adverse Event Report: ROCHE DIAGNOSTICS AMYL GEN.2; LIPASE HYDROLYSIS/GLYCEROL KINASE ENZYME, TRIGLYCERIDES

Catalog Number	03183742122
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received questionable results for one patient sample tested with amylase (amyl2) on a cobas 6000 c 501 module (b)(6).The results did not agree with the clinical status of the patient.The sample initially resulted in an amylase value of 133 u/l and repeated as 135 u/l.The results were reported outside of the laboratory and questioned by the patient's doctor.A second sample was also collected from the patient on (b)(6) 2023 and tested, resulting in an amylase value of 146 u/l.
Additional Manufacturer Narrative
Calibration and qc were acceptable.There were no questionable results for other patients tested for amyl2.There were no issues with other tests run on the instrument.The investigation is ongoing.H3 other text : na.
Additional Manufacturer Narrative
Based on a review of worldwide data of the reagent and the control lot used by the customer, no qc issues were found, therefore, a general reagent issue can be excluded.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: AMYL GEN.2
• Common Device Name: LIPASE HYDROLYSIS/GLYCEROL KINASE ENZYME, TRIGLYCERIDES
• 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: 17021815
• Report Number: 1823260-2023-01778
• Device Sequence Number: 12653831
• Product Code: CDT
• UDI-Device Identifier: 04015630918935
• UDI-Public: 04015630918935
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K972250
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• 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): 06/23/2023

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: 11/30/2023
• Device Catalogue Number: 03183742122
• Device Lot Number: 677165
• 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: 05/04/2023
• Supplement Date Received by Manufacturer: 06/12/2023
• Initial Report FDA Received Date: 05/30/2023
• Supplement Report FDA Received Date: 06/23/2023
• 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: ASPIRIN.
• Patient Sex: Unknown