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

Catalog Number 04912551190

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/24/2021

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Medwatch field lot number: january 2022, november 2021.Medwatch field udi number: (b)(4).

Event Description

The initial reporter stated they received questionable results for three samples collected from the same patient and tested with d-di tina-quant d-dimer gen.2 on a cobas 6000 c (501) module.All results were reported outside of the laboratory to the doctor and patient.The results did not agree with the clinical picture of the patient.The first complained sample from the patient resulted in a d-dimer value of 5.78 ug/ml (reference range = < 0.5 ug/ml) when tested on the c501 analyzer with d-dimer reagent lot number 519645 (expiration date = january 2022).The second complained sample from the patient resulted in a d-dimer value of 9.01 ug/ml when tested on the c502 analyzer on 08-apr-2021 with d-dimer reagent lot number 509145 (expiration date = november 2021).On 09-apr-2021, another sample from the patient was tested in a second laboratory using the acl top-700 hemostasis analyzer, resulting in a d-dimer value of 111 ng/ml (reference range = 0.0 - 243 ng/ml).On 10-apr-2021, another sample from the patient was tested in a third laboratory using a d-dimer compact analyzer, resulting in a value of 0.47 ngfeu/ml (reference range = < 0.5 ngfeu/ml).The third complained sample from the patient resulted in a d-dimer value of 7.82 ug/ml when tested on the c501 analyzer on 14-apr-2021 with d-dimer reagent lot number 509145.The second complained sample was kept frozen and defrosted.This sample was also repeated on the c501 analyzer on 14-apr-2021, resulting in a d-dimer value of 8.8 ug/ml.The serial number of the c501 analyzer is (b)(4).

Manufacturer Narrative

The customer stated that control recovery was fine.The investigation could not identify a product problem.The cause of the event could not be determined.There was no remaining sample available for further investigation.

• 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: 11836023
• MDR Text Key: 251219013
• Report Number: 1823260-2021-01469
• 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: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2021
• 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: 519645, 509145
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EGILOK; RIVORAXABAN (XARELTO)
• Patient Age: 38 YR