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

Catalog Number 03001245322

Device Problem High Test Results (2457)

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

Event Date 07/25/2021

Event Type  malfunction  

Manufacturer Narrative

The sample was requested for investigation.The sample was not available for investigation.The calibration and qc data were requested but not provided.Due to limited information and data provided a clear root cause could not be determined.There was no general product problem found, the product meets specifications.The investigation did not identify a product problem.The cause of the event could not be determined.

Event Description

The initial reporter received questionable d-di tina-quant d-dimer results for one patient sample with the cobas 6000 c501 module serial number (b)(4).The initial result was 4677 ng/ml.This result was reported outside of the laboratory and questioned by the physician.The repeated result was 4550 ng/ml.The physician questioned this result as well.The customer sent the sample to three different laboratories for repeat testing.The first laboratory tested the sample with a cobas c501 using a reagent from a third party and received a result of 474 ng/ml (cutoff < 250 ddu ng/ml).The second laboratory tested the sample with a cobas c502 using a roche reagent and received a result of 5.1 mg/l (cutoff 0.5 feu mg/l).On (b)(6) 2021, the third laboratory tested the sample with a siemens analyzer and received a result of 0.9 feu mg/l.

• Brand Name: D-DI TINA-QUANT 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: 12369463
• MDR Text Key: 268243400
• Report Number: 1823260-2021-02473
• Device Sequence Number: 1
• Product Code: GHH
• UDI-Device Identifier: 04015630914593
• UDI-Public: 04015630914593
• Combination Product (y/n): N
• Reporter Country Code: PK
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 03001245322
• Device Lot Number: 538196
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2021
• 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
• Patient Age: 59 YR