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 11/17/2020

Event Type  malfunction  

Manufacturer Narrative

The patient sample was provided for investigation and the values obtained by the customer could be reproduced.The investigation is ongoing.This event occurred in (b)(6).

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with d-di tina-quant d-dimer gen.2 on a cobas 8000 c 502 module.The initial value was reported outside of the laboratory.The heparin plasma tube of the sample initially resulted with a d-dimer value of 4806 ug/l when tested on the c502 analyzer.This same tube was repeated twice on the same analyzer (b)(6) 2020, resulting with values of 4666 ug/l accompanied by a data flag and 4775 ug/l accompanied by a data flag.The edta plasma tube of the sample was also repeated twice on the same analyzer on (b)(6) 2020, resulting with values of 4930 ug/l accompanied by a data flag and 4931 ug/l accompanied by a data flag.The heparin plasma tube was repeated on a cobas h 232 analyzer on (b)(6) 2020, resulting with a value of 170 ug/l.The edta plasma tube was also repeated on the cobas h 232 analyzer on (b)(6) 2020, resulting with a value of 140 ug/l.The values from the cobas h232 analyzer were believed to be correct.The patient was sent to the clinic based on the c 502 value and a new sample collected from the patient there was tested on a sta instrument using the sta liatest d-di plus reagent, resulting with a d-dimer value in the range of 200 ul/l.The patient was then sent home.The serial number of the c502 analyzer is (b)(4).

Manufacturer Narrative

The investigation performed additional dilution testing on the patient sample for d-dimer, as well as performed an igg test without a dilution to determine the concentration of igg within the sample.The investigation found that the igg concentration was within the expected range for adults, and with the dilutions, the result for d-dimer decreased.The investigation concluded although the igg value is within the expected range for adults, it is likely that a non-specific agglutination caused by certain immunoglobulins leads to falsely high d-dimer 2 results.This interference is mentioned in the current method sheet for d-dimer 2 under the section "limitations interference": "in rare cases (less than 1 reported case per 100000 tests) certain immunoglobulins can cause a non-specific agglutination leading to falsely high results." since the controls were well within the specifications, no reagent specific issue could be identified.The reagent meets specifications.

• 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: 11012997
• MDR Text Key: 244329883
• Report Number: 1823260-2020-03211
• 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: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 04912551190
• Device Lot Number: 49702801
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NO MEDICATION.