MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ROCHE CARDIAC D-DIMER; FIBRINOGEN AND FIBRIN SPLIT PRODUCTS

Catalog Number 04877802190

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/22/2019

Event Type  malfunction  

Manufacturer Narrative

The event occurred in: (b)(6).

Event Description

The initial reporter complained of questionable roche cardiac d-dimer results for 1 patient tested on three cobas h 232 meters.From meter serial number (b)(4) the result was 1.29 ug/ml.From meter serial number (b)(4) the result was 0.91ug/ml.From meter serial number (b)(4) the result was 0.85 ug/ml.On (b)(6) 2019 the customer provided additional patient data: from meter serial number (b)(4) the result was 3.81 ug/ml.From meter serial number (b)(4) the result was 3.57 ug/ml.From meter serial number (b)(4) the result was 1.82 ug/ml.The customer stated that they only run qc testing on meter serial number (b)(4).The customer did not run any qc testing on meter serial number (b)(4).It was unknown if the discrepant results were reported outside of the laboratory.There was no allegation of an adverse event.The investigation is currently ongoing.

Manufacturer Narrative

Relevant retention material for roche cardiac d-dimer of lot 38650510 was measured on a qualified cobas h 232 meter.The measurement results fulfilled the requirements.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ROCHE CARDIAC D-DIMER
• Type of Device: FIBRINOGEN AND FIBRIN SPLIT PRODUCTS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 8687392
• MDR Text Key: 147611765
• Report Number: 1823260-2019-02148
• Device Sequence Number: 1
• Product Code: GHH
• Combination Product (y/n): N
• PMA/PMN Number: K033491
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 04877802190
• Device Lot Number: 38650510
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR