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 09/04/2019

Event Type  malfunction  

Manufacturer Narrative

The event occurred in (b)(6).

Event Description

The initial reporter complained of questionable high d-di tina-quant d-dimer gen.2 results for 1 patient tested on a cobas 8000 c 502 module.The c 502 serial number was (b)(4).The initial d-dimer result on the c 502 was 8438 ng/ml and was reported outside of the laboratory.A new sample was collected and the d-dimer result on a different instrument was normal.The specific date and time the sample was collected were not provided.The specific instrument and result were asked for but not provided.On (b)(6) 2019 the initial sample was repeated and the d-dimer results on the c 502 were 8174 ng/ml and 8271 ng/ml with a data alarm.On (b)(6) 2019 the initial sample was repeated and the d-dimer results on a cobas h232 meter were 140 ng/ml and 150 ng/ml.

Manufacturer Narrative

The customer returned a sample for investigation.The investigation identified a non-specific immunoglobulin interference.This interferent is covered in product labeling."in very rare cases, gammopathy, in particular type igm (waldenström¿s macroglobulinemia), may cause unreliable results.In rare cases (less than 1 reported case per 100000 tests) certain immunoglobulins can cause a non-specific agglutination leading to falsely high results.".

• 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: 9149913
• MDR Text Key: 216377962
• Report Number: 1823260-2019-03537
• 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: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 04912551190
• Device Lot Number: 42427101
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 38 YR