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

Catalog Number	07190794190
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2023
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.
Additional 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
• Common Device Name: 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
• Report Number: 1823260-2023-02961
• Device Sequence Number: 17745214
• Product Code: JHS
• UDI-Device Identifier: 04015630940806
• UDI-Public: 04015630940806
• Combination Product (Y/N): Y
• Initial Reporter Country: GR
• PMA/510(K) Number: K951595
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2023

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: 08/31/2023
• Device Catalogue Number: 07190794190
• Device Lot Number: 68796601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/17/2023
• Supplement Date Received by Manufacturer: 09/14/2023
• Initial Report FDA Received Date: 09/12/2023
• Supplement Report FDA Received Date: 09/15/2023
• 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 Sex: Unknown