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

Catalog Number	07190794190
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer simulated the situation again and a data flag was present on the sample.Based on the provided data and information, the investigation determined the event was consistent with an issue related to the sample concentration.A possible analyzer contribution regarding one sample without an alarm could not be investigated due to missing reaction kinetics.Based on the quality control data, a general problem with the reagent could be ruled out.
Event or Problem Description
There was an allegation of a questionable creatinine kinase (ck) result from the cobas 6000 c501 module serial number (b)(4).In the afternoon at 18:04, the initial result for sample 1 was 733 u/l (with no data flag) and was reported outside of the laboratory.Later in the evening around 22:00, sample 2 was drawn from the patient and the ck result was 2505 u/l with a data flag.With a 1:50 dilution, the result was 34941 u/l.Sample 1 was then repeated at 22:45 with a 1:50 dilution and the result was 37337 u/l.

• 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: 16726441
• Report Number: 1823260-2023-01230
• Device Sequence Number: 7209581
• Product Code: JHS
• UDI-Device Identifier: 04015630940806
• UDI-Public: 04015630940806
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/12/2023

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: 06/30/2023
• Device Catalogue Number: 07190794190
• Device Lot Number: 66484301
• 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: 03/28/2023
• Initial Report FDA Received Date: 04/12/2023
• 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
• Patient Sex: Unknown