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

Catalog Number	07190794190
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about discrepant results for 1 patient's plasma sample tested with creatine kinase (ck) assay on a cobas 6000 c501 (ul) v serial number (b)(6).The initial result was 19 u/l.The repeat results were 8076 u/l with a data flag and 9785 u/l.The results were obtained from a single sample.The questionable result was reported outside the laboratory.The physician questioned the result and the sample was repeated.The repeat result deemed to be the correct result.
Additional Manufacturer Narrative
The customer mentioned that daily maintenance is done on time.The sample was visually checked and it looked fine.The field service engineer (fse) verified alignments, cell rinse levels, probe rinse volumes, and pump pressures.Precision studies were performed and they were within specifications.Qc was performed and was acceptable.Investigation is ongoing.
Additional Manufacturer Narrative
The initial report stated: we received an allegation about discrepant results for 1 patient's plasma sample tested with creatine kinase (ck) assay on a cobas 6000 c501 (ul) v serial number (b)(6).This should say: we received an allegation about discrepant results for 1 patient's plasma sample tested with creatine kinase (ck) assay on a cobas 6000 c (501) module serial number (b)(6).
Additional Manufacturer Narrative
Device code (a code) was updated.The service actions done and reported in the intial report resolved the issue.An instrument performance check was conducted and the instrument was operating within specifications.No further issues were reported afterwards.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16809455
• Report Number: 1823260-2023-01390
• Device Sequence Number: 2959601
• Product Code: JHS
• UDI-Device Identifier: 04015630940806
• UDI-Public: 04015630940806
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/16/2023

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: 03/31/2023
• Device Catalogue Number: 07190794190
• Device Lot Number: 64686701
• 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: 03/31/2023
• Supplement Date Received by Manufacturer: 05/01/2023; 05/22/2023
• Initial Report FDA Received Date: 04/25/2023
• Supplement Report FDA Received Date: 05/29/2023; 06/16/2023
• 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: CEFTHROXIANE SODIUM.; DEPTHROYMYCIN.; DEXTROSE IV.; TYLENOL.
• Patient Sex: Male