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 04/24/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Unique identifier (udi)#: (b)(4).The patient was born in (b)(6).

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 6000 c (501) module - c501.The erroneous results were reported outside of the laboratory to a doctor.The sample initially resulted with a ddi value of 3.34 mg/l feu accompanied by a data flag.The sample was automatically repeated, resulting as 3.33 mg/l feu accompanied by a data flag.The patient was sent to the hospital based on the c501 value.At the hospital, the patient was tested for ddi using sysmex analyzer which used siemens reagent.The result from the sysmex analyzer was normal, so no treatment was provided.On (b)(6) 2018, the sample was repeated on the c501 analyzer, resulting as 3.31 mg/l feu accompanied by a data flag.The sample was automatically repeated, resulting as 3.33 mg/l feu accompanied by a data flag.The sample was sent to another laboratory where it was measured using the same type of analyzers.On a second c501 analyzer at the other site, the sample resulted as 3.58 mg/l feu.On a sysmex analyzer at the other site, the sample resulted with a value that was under the limit of detection.No adverse events were alleged to have occurred with the patient.The c501 analyzer serial number was (b)(4).

Manufacturer Narrative

A sample from the patient was provided for investigation.Investigations of the sample were able to duplicate the results obtained by the customer.A 1:5 dilution of the sample did not show linear dilution behavior, but the result was accompanied by a data flag which invalidated the result.The measurements did not indicate that an interfering factor was present.

Manufacturer Narrative

Upon review of the calibration data, frequent calibration failures were observed.Quality controls were within range on (b)(6) 2018.Quality control recovery was generally good.Abnormal probe aspiration alarms occurred on (b)(6) 2018.Reagent warning level alarms occurred on (b)(6) 2018.Further investigation of the sample showed decreasing ddi results when the sample was diluted.This indicates interference.The igm result was also above the normal range, which could indicate a gammopathy interference.Product labeling lists immunoglobulin interference as a potential limitation of the assay.Sample measurements did not indicate an interference by rheumatoid factors or fibrinogen.

• 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: 7507855
• MDR Text Key: 108381369
• Report Number: 1823260-2018-01459
• 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,Followup
• Report Date: 07/30/2018

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: 290802
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/26/2018
• Initial Date FDA Received: 05/11/2018
• Supplement Dates Manufacturer Received: 04/26/2018; 04/26/2018
• Supplement Dates FDA Received: 07/12/2018; 07/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONTRACEPTIVE
• Patient Age: 22 YR