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

Catalog Number 07190794190

Device Problem High Test Results (2457)

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

Event Date 06/27/2022

Event Type  malfunction  

Manufacturer Narrative

The calibration and qc data were acceptable, therefore a general reagent issue was ruled out.The investigation is ongoing.

Event Description

There was an allegation of questionable ck creatine kinase results from cobas 6000 c 501 module serial number (b)(4) due to interference.Sample 1 initial result was 500 u/l.The repeat result with a dilution was >57000 u/l.As this did not match the clinical picture for the patient, a new sample was drawn.Sample 2 initial result was 7 u/l with a data flag.The repeat result with a reduced sample volume was 47072 u/l with a data flag.On another analyzer, the initial result was 1339 u/l with a data flag.The repeat result with a reduced sample volume was 46386 u/l with a data flag.Additional results from (b)(6) 2022 of 1222 u/l with a data flag and 46255 u/l were provided.From (b)(6) 2022, results of 2971 u/l with a data flag and 32794 u/l were provided.It is unclear from which sample these results were generated.The questionable results were reported outside of the laboratory.

Manufacturer Narrative

The investigation did not identify a product problem.The cause of the event could not be determined.Based on the provided data and information, a general reagent issue could be ruled out as calibration and qc data are acceptable.The issue is consistent with a patient/sample condition 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15070073
• MDR Text Key: 304795157
• Report Number: 1823260-2022-02149
• Device Sequence Number: 1
• Product Code: JHS
• UDI-Device Identifier: 04015630940806
• UDI-Public: 04015630940806
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 08/17/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 07190794190
• Device Lot Number: 61098301
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/27/2022
• Initial Date FDA Received: 07/20/2022
• Supplement Dates Manufacturer Received: 07/25/2022
• Supplement Dates FDA Received: 08/17/2022
• 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
• Treatment: B1; B6
• Patient Sex: Male