MAUDE Adverse Event Report: ROCHE DIAGNOSTICS 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 01/19/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6).This event occurred in (b)(6).

Event Description

The customer complained of erroneous results for 1 patient sample tested for tina-quant d-dimer (d-di).The erroneous results were reported outside of the laboratory.The initial result from a lithium heparin sample on the integra 400 plus was 1756 ng feu/ml.The lithium heparin sample was repeated on the integra 400 plus and the result was 1760 ng feu/ml.The lithium heparin sample was repeated twice using the aqt 90 flex method and the results were 302 ng feu/ml and 320 ng feu/ml.The result from an edta whole blood sample from the aqt 90 flex method was 386 ng feu/ml.The patient had an ultrasound test for deep vein thrombosis (dvt) which was negative.The customer concluded that the elevated d-di result was due to an asthma attack and not dvt.No adverse event occurred.The integra 400 plus analyzer serial number (b)(4).

Manufacturer Narrative

The patient sample was submitted for investigation.The results from the dilution experiment indicate a non-specific cross-reaction in the sample.Product labeling indicates that certain immunoglobulins can cause non-specific agglutination leading to falsely elevated results.These immunoglobulins most likely caused the high result the customer obtained.

• Brand Name: D-DIMER
• Type of Device: FIBRIN SPLIT PRODUCTS
• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 5514237
• MDR Text Key: 40795455
• Report Number: 1823260-2016-00334
• 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: Initial,Followup
• Report Date: 05/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Catalogue Number: 04912551190
• Device Lot Number: 617498
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2016
• 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