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

Catalog Number 04912551190

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/26/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer stated that they received an erroneous result for one patient sample tested for tina-quant d-dimer gen.2 (ddi) on a c501 analyzer.The sample initially resulted as 0.18 ug/ml.The sample was repeated, resulting as 0.18 ug/ml.The 0.18 ug/ml value was reported outside of the laboratory.The patient was later evaluated by doppler and it was found that the patient had a venous thrombosis.The patient is currently in good health and was not adversely affected.The serial number of the c501 analyzer was asked for, but not provided.The customer ran precision studies.The patient sample was provided for investigation and investigations were able to confirm the customer's results.Dilution experiments performed with the sample seem to confirm the low result.The performance of the reagent seems to be within specification.Interference is less likely since dilution yielded similar results.A specific root cause could not be identified.

Manufacturer Narrative

According to product labeling, patients with a distal dvt or a subsegmental/peripheral pe may have a normal ddi result.A product problem could not be seen.

• 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: 5783414
• MDR Text Key: 49248126
• Report Number: 1823260-2016-00889
• Device Sequence Number: 1
• Product Code: GHH
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 07/18/2016

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 Catalogue Number: 04912551190
• Device Lot Number: 619845
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/30/2016
• Initial Date FDA Received: 07/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/19/2016
• 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