MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CREATINE KINASE; CPK, DIFFERENTIAL RATE KINETIC METHOD

Catalog Number 08057460190

Device Problems High Test Results (2457); Output Problem (3005)

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

Event Date 01/16/2024

Event Type  malfunction  

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with creatine kinase on a cobas pro c 503 analytical unit.The sample initially resulted in a ck value of > 2195 u/l with a data flag.The sample was automatically repeated with decreased sample volume, resulting in a value of 209 u/l.Since the repeat value obtained with decreased sample volume did not agree with the initial value, the sample was repeated a second time, resulting in a value that was below the assay measuring range and flagged.The specific value was not provided.The sample was tested on a second analyzer, resulting in a ck value of 2218 u/l.The sample was repeated on the complained analyzer on (b)(6)2024, resulting in a ck value of > 2187 u/l with a data flag.The sample was then automatically repeated with decreased sample volume, resulting in a ck value of 2277 u/l.

Manufacturer Narrative

The field service engineer visited the site on 16-jan-2024 as the analyzer had a pressure error.A probe was replaced.Calibrations were performed and controls recovered within range.Some bubbles were observed in a different reagent pack and the pack was replaced.Performance testing recovered within specifications.The issue occurred again after the service actions.The engineer returned on 19-jan-2024 and performed mechanism checks.The cuvette wash adjustment was checked and was ok.The syringe seals were replaced and an air purge was performed.The lamp, cuvettes, and heat cut filter were replaced.A cell blank was performed.Calibration and controls were performed and were ok.No further issues occurred after these actions.Calibration data was acceptable.One level of quality control was outside of range on the day of the event, but was acceptable most of the time.The second level of control was acceptable.A general reagent issue could be ruled out because calibration and controls were acceptable.The investigation is ongoing.

Manufacturer Narrative

A general reagent issue can be ruled out as calibration and controls are acceptable.The investigation determined the service actions resolved the issue.

• Brand Name: CREATINE KINASE
• Type of Device: CPK, DIFFERENTIAL RATE KINETIC METHOD
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 18635617
• MDR Text Key: 334491321
• Report Number: 1823260-2024-00308
• Device Sequence Number: 1
• Product Code: JHS
• UDI-Device Identifier: 07613336121122
• UDI-Public: 07613336121122
• Combination Product (y/n): Y
• Reporter Country Code: BR
• PMA/PMN Number: K191899
• 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: 02/09/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: 08057460190
• Device Lot Number: 744192
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2024
• Initial Date FDA Received: 02/02/2024
• Supplement Dates Manufacturer Received: 02/08/2024
• Supplement Dates FDA Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1