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

Catalog Number 04912551190

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2019

Event Type  malfunction  

Manufacturer Narrative

The country of origin is (b)(6).The samples have been requested for return.

Event Description

The initial reporter received questionable d-dimer results from the cobas 6000 c501 module analyzer serial number of (b)(4).The initial result (reagent lot 43513101, expiration date: 31-aug-2020) was 5017 ng/ml and the rerun result (reagent lot 44724601, expiration date: 31-oct-2020) was 4400 ng/ml.On (b)(6) 2019, on a siemens analyzer, the rerun result was 320 ng/ml.The questionable results were reported outside the laboratory.

Manufacturer Narrative

The findings of the investigation of the patient sample were consistent with a non-specific igg interferent.This is mentioned in the package insert.In rare cases (less than 1 reported case per 100000 tests) certain immunoglobulins can cause a non-specific agglutination leading to falsely high results.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings no product problem was found, product meets specification.

• Brand Name: D-DIMER
• Type of Device: FIBRIN SPLIT PRODUCTS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 9503869
• MDR Text Key: 218710650
• Report Number: 1823260-2019-04489
• Device Sequence Number: 1
• Product Code: GHH
• Combination Product (y/n): N
• PMA/PMN Number: K062203
• 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: 01/31/2020

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: 10/31/2020
• Device Catalogue Number: 04912551190
• Device Lot Number: 44724601, 43513101
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/26/2019
• Initial Date FDA Received: 12/20/2019
• Supplement Dates Manufacturer Received: 11/26/2019
• Supplement Dates FDA Received: 01/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TOLURA