MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS CK-MB; CPK OR ISOENZYMES, COLORIMETRIC METHOD

Catalog Number	07027087190
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	02/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter address: (b)(6).Qc was acceptable on the date of the event.Five sample-related alarms were observed on the alarm trace data.Precision testing was performed.The original sample was stored for 3 days at 2 8 °c.Product labeling states the sample is: "stable for 5 hours at 20 25 °c, 12 hours at 2 8 °c, 3 months at 20 °c (± 5 °c).Freeze only once.Ck mb stability is extremely temperature-dependent.A ck mb decrease of > 10 % can occur after the sample has stood for 1 hour at 32 °c." the patient suffers from myeloproliferative neoplasms (mpn), and when using heparin tubes the blood viscosity increases.This may lead to a drop at the tip of the sample probe, which could lead to a high result.Clots could also influence the results.Based on the data provided, the cause of the event could not be determined.A general reagent issue can be excluded.Qc data does not suggest a general reagent or instrument issue.The investigation did not identify a product problem.
Event or Problem Description
The initial reporter complained of a discrepant high result for 1 patient sample tested for elecsys ck-mb (ck-mb) on a cobas e 801 analytical unit.The initial result was 83.8 ng/ml.This result was reported outside of the laboratory.On (b)(6) 2023 a new sample was obtained and the ck-mb result was 1.65 ng/ml.The customer noted that the initial ck-mb result was greater than the patient's initial ck result and pulled the original sample for re-testing.On (b)(6) 2023 the original sample was repeated with a ck-mb result of 2.52 ng/ml.The e801 module serial number was (b)(4).

• Brand Name: ELECSYS CK-MB
• Common Device Name: CPK OR ISOENZYMES, COLORIMETRIC METHOD
• 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: 16600627
• Report Number: 1823260-2023-00941
• Device Sequence Number: 5923948
• Product Code: JHY
• UDI-Device Identifier: 04015630939978
• UDI-Public: 04015630939978
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K132571
• 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): 03/23/2023

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: 07027087190
• Device Lot Number: 60799001
• 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: 02/26/2023
• Initial Report FDA Received Date: 03/23/2023
• 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 Age: 76 YR
• Patient Sex: Male