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

Catalog Number 07190794190

Device Problems Low Test Results (2458); Non Reproducible Results (4029)

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

Event Date 12/05/2022

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 313168892
• Report Number: 1823260-2023-01230
• Device Sequence Number: 1
• Product Code: JHS
• UDI-Device Identifier: 04015630940806
• UDI-Public: 04015630940806
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K951595
• 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
• Report Date: 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 03/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1