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

Catalog Number 03183742122

Device Problem Incorrect Measurement (1383)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/04/2023

Event Type  malfunction  

Event 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.

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.

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
• Type of Device: 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
• MDR Text Key: 317065061
• Report Number: 1823260-2023-01778
• Device Sequence Number: 1
• Product Code: CDT
• UDI-Device Identifier: 04015630918935
• UDI-Public: 04015630918935
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K972250
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 06/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASPIRIN.