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

Catalog Number 04912551190

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/29/2017

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).(b)(4).

Event Description

The customer stated that they received erroneous results for one patient sample tested for d-di tina-quant d-dimer gen.2 (ddi) on a cobas integra 400 plus (i400+).The erroneous results were reported outside of the laboratory.The sample initially resulted as 6584 ng/ml when tested on the i400+.The sample was repeated on the i400+ on (b)(6) 2017, resulting as 6436 ng/ml.The sample was repeated on a mini vidas analyzer on (b)(6) 2017, resulting as 233 ng/ml.No adverse events were alleged to have occurred with the patient.The i400+ analyzer serial number was asked for, but not provided.The calibration and quality control results were fine.

Manufacturer Narrative

The measurements performed on the i400+ seem to be okay.Calibration and quality controls were fine and duplicate measurement of the patient sample was in agreement.A specific root cause could not be determined based on the provided information.The sample was not available for investigation.The large differences between the vidas system and the i400+ can only be explained by a sample mix-up or an interferent in the sample.

• 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: 6890962
• MDR Text Key: 89522990
• Report Number: 1823260-2017-02071
• Device Sequence Number: 1
• Product Code: GHH
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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,Followup
• Report Date: 11/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 216122
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/04/2017
• Initial Date FDA Received: 09/25/2017
• Supplement Dates Manufacturer Received: 09/04/2017
• Supplement Dates FDA Received: 11/21/2017
• 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: 53 YR