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 11/09/2021

Event Type  malfunction  

Manufacturer Narrative

The sample was requested for investigation.

Event Description

The initial reporter complained of discrepant high results for 1 patient sample tested for d-dimer on a cobas 6000 c (501) module compared to the stago method.The initial result from the c501 module was 8026 ng/ml with a data flag.The repeat result in decreased mode was 21467 ng/ml with a data flag.The sample was repeated on the c501 module using a 1:20 dilution and the result was 131593 ng/ml.This result was reported outside of the laboratory where it was questioned by the patient.The sample was sent to another laboratory using the stago method and the result was 190 ng/ml.The c501 module serial number was (b)(4).

Manufacturer Narrative

The patient went to a laboratory running d-dimer on an h232 instrument and the result was 0.28 ug/ml (280 ng/ml).Two samples from the patient were submitted for investigation and run on a c501 module with reagent lot 528687.The samples were run normal, decreased and manually diluted (1:10 and 1:20): normal: 8280 ng/ml and 8131 ng/ml both with > proz flags.Decrease: 22492 ng/ml and 22185 ng/ml both with > test flags.1:10: 10799 ng/ml and 11342 ng/ml both with > test flags.1:20: 111260 ng/ml and 129600 ng/ml.The investigation is ongoing.

Manufacturer Narrative

The two samples were investigated further.The investigation determined the high d-dimer results were consistent with a non-specific reaction with the immunoglobulin a (iga) component of the reagent.The investigation did not identify a product problem.

• 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: 12911142
• MDR Text Key: 287423602
• Report Number: 1823260-2021-03549
• Device Sequence Number: 1
• Product Code: GHH
• Combination Product (y/n): N
• Reporter Country Code: JO
• PMA/PMN Number: K062203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 04912551190
• Device Lot Number: 52868701
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2022
• 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
• Patient Sequence Number: 1
• Treatment: ATECAND