MAUDE Adverse Event Report: ROCHE DIAGNOSTICS D-DI TINA-QUANT D-DIMER GEN. 2; FIBRIN SPLIT PRODUCTS

Catalog Number 04912497190

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/24/2017

Event Type  malfunction  

Manufacturer Narrative

B4.

Event Description

The field application specialist stated the customer received questionable d-di tina-quant d-dimer gen.2 results for multiple samples from one patient.The patient has liver failure and the coagulation "is strongly interrupted".Therefore the patient was tested every day and fibrinogen and thrombocytes were given if needed.The patient was first tested on (b)(6) 2017.From (b)(6) 2017 to (b)(6) 2017, all results were almost 9000 ng/ml which was around the test range maximum and many had data flags.These results were rejected by the laboratory on (b)(6) 2017 and labeled as possibly wrong.There was no sample material remaining to repeat testing for these dates.Samples from (b)(6) 2017 to (b)(6) 2017 were repeated with various dilutions and corrected reports were issued for some of the samples.No medical action was taken based on the reported incorrect results.There was no adverse event a high dose hook effect, non-specific agglutination, or interference was suspected.The customer used a modular p800 module.The serial number was requested but was not provided.

Manufacturer Narrative

Patient 1 died "some weeks after" the erroneous result were generated.The customer could not provide the specific date.The cause of death was "strong liver dysfunction." the device did not cause or contribute to the any incorrect medical decision for the patient.The customer received questionable results for a second patient on (b)(6) 2017.This patient was (b)(6).Sample 1: the initial result was 8510 ng/ml and was reported outside the laboratory.The repeat result with a 1:5 manual dilution was 21305 ng/ml.Sample 2: the result undiluted was 8140 ng/ml.The repeat result with a 1:5 manual dilution was 15885 ng/ml.Sample 3: the result undiluted was 9633 ng/ml with a data flag and repeated with a decreased sample volume was 22131 ng/ml with a data flag.The repeat result with a 1:5 automatic dilution was 42334 ng/ml.The reported result was corrected and the doctor was informed.For two of the three samples, the volume drawn was low because the patient was very weak but the third sample was a normal volume.The patient died in between the sample draws.The patient had a meningococcal infection.The device did not cause or contribute to the any incorrect medical decision for the patient.Additional information was provided that the customer is a specialist on liver dysfunction who reported both patients were seriously ill.

Manufacturer Narrative

Samples from both patients were submitted for investigation and it was confirmed that the d-dimer results increased when the samples were diluted.Based on the available information, a specific root cause could not be determined.A general reagent issue could be excluded based on the provided calibration and qc results.

• Brand Name: D-DI TINA-QUANT D-DIMER GEN. 2
• 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: 6584826
• MDR Text Key: 75874803
• Report Number: 1823260-2017-01080
• Device Sequence Number: 1
• Product Code: GHH
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K062203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04912497190
• Device Lot Number: 187661
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2017
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 1 MO