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

Catalog Number 04912551190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/02/2015

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer received questionable d-dimer results for one patient sample.The patient was known to have results > 7500ug/l since 2010.The specific date of the event was requested, but was not provided.The initial result from integra 400 plus analyzer serial number (b)(4) was >7500 ug/l with a data flag.The repeat result was 18000 ug/l.The same sample was tested on a cobas6000 analyzer and the result was 7573 ug/l.The sample was then tested on a vidas analyzer and the result was 920 ug/l.The results were reported outside of the laboratory.The patient was not adversely affected and was did not receive any special treatment.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

The sample in question was sent to another laboratory and the results were provided as: "innovance siemens 950 and 920 tq roch c8000 4740 and 4770 stago sta lia-dd 1030 and 990 fdp test: 4,6 ug/ml (ref < 5 ug/ml) = normal comment second lab: "there seems to be no high degradation of fibine, which is equivalent to our hypothesis that something bothers in the dd test.".

Manufacturer Narrative

Sample from the patient was submitted for investigation and it was found a non-specific reaction from igm could have caused the high d-dimer result.The correct d-dimer result for the sample was thought to have been 1.08 ug feu/ml based on the converted values after absorption with anti-igm antibody.Product labeling documents in rare cases, specific immunoglobulins, particularly in samples from patients with myeloma, can give falsely high results.

• Brand Name: TINA-QUANT D-DIMER
• Type of Device: FIBRIN SPLIT PRODUCTS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 5093545
• MDR Text Key: 26483998
• Report Number: 1823260-2015-04201
• Device Sequence Number: 1
• Product Code: GHH
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K062203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Followup
• Report Date: 12/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04912551190
• Device Lot Number: 61323101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 09/02/2015
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 065 YR