MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CKMBL CREATINE KINASE-MB; CPK OR ISOENZYMES

Catalog Number 07190794190

Device Problems High Test Results (2457); Non Reproducible Results (4029)

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

Event Date 07/31/2023

Event Type  malfunction  

Event Description

There was an allegation of questionable creatinine kinase (ck) results for one patient from two cobas 501 analyzers.Different samples from the same child, taken a few hours apart, had differences in ck values of thousands of iu.At 16.00 pm, sample 1 tested on analyzer serial number (b)(6) had a result of greater than 5000 iu.The repeat result with a dilution was 5800 iu.The same sample was tested with a dilution on analyzer serial number (b)(6) and the result was 6000 iu.Sample 2 was drawn at 22.00 pm and was tested on analyzer serial number (b)(6) with a result of 70 iu.This sample was then tested on analyzer serial number (b)(6) with a result of 68 iu.On (b)(6) 2023, the customer retested the same samples.Sample 1 result from analyzer serial number (b)(6) with a dilution was 5894 iu.Sample 1 result from analyzer serial number (b)(6) with a dilution was 6000 iu.The result for sample 2 using analyzer serial number (b)(6) was 70 iu.The result for sample 2 using analyzer serial number (b)(6) was 68 iu.The result from a third sample drawn from the patient and tested on analyzer serial number (b)(6) was 67 iu.

Manufacturer Narrative

The customer also used reagent lot 717270.The expiration date was not provided.Based on the calibration and qc data, a general reagent issue could be excluded.The investigation is ongoing.

Manufacturer Narrative

The investigation did not identify a product problem.The cause of the event could not be determined.The event was constant with a sample quality issue.

• Brand Name: CKMBL CREATINE KINASE-MB
• Type of Device: CPK OR ISOENZYMES
• 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: 17731157
• MDR Text Key: 323330763
• Report Number: 1823260-2023-02961
• Device Sequence Number: 1
• Product Code: JHS
• UDI-Device Identifier: 04015630940806
• UDI-Public: 04015630940806
• Combination Product (y/n): Y
• Reporter Country Code: GR
• PMA/PMN Number: K951595
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 07190794190
• Device Lot Number: 68796601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2023
• 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