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 Consequences Or Impact To Patient (2199)

Event Date 05/11/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer is questioning high results for 3 samples from the same patient tested for d-di tina-quant d-dimer (ddi) on a cobas 6000 c (501) module - c501.The high results were reported outside of the laboratory.The first sample resulted as 12.62 ug feu/ml.The second sample resulted as 13.11 ug feu/ml on (b)(6) 2016.The third sample resulted as 11.75 ug feu/ml on (b)(6) 2016.A fourth sample from the patient was tested at a different site on (b)(6) 2016 using the siemens bcs-xp quantitative immuno-turbidimetric method, resulting with a normal value of 0.5 ug feu/ml.The customer is not sure which results are correct.The customer stated they don't suspect that the patient has blood clots but the patient does have ehlers-danlos hypermobile type (connective tissue disorder) and the customer is not sure if this could cause an issue with ddi results.The patient was not treated based on the results from the c501 analyzer.The patient was not adversely affected.The c501 analyzer serial number was (b)(4).The customer declined a service visit; they believe the issue is with the patient samples and not with the device.

Manufacturer Narrative

The customer's quality control results have been in range as well as linearity and surveys.Product labeling which indicates that igm in patients with myeloma can cause false high results.The investigation stated that the patient has ehlers-danlos disease, but not cancer.A specific root cause could not be identified.Since no sample from the patient is available, the investigation cannot be completed.No other potential interferences are known.

• 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: 6145956
• MDR Text Key: 61501184
• Report Number: 1823260-2016-01894
• Device Sequence Number: 1
• Product Code: GHH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/05/2017

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: 03001245322
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/11/2016
• Initial Date FDA Received: 12/05/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/05/2017
• 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
• Treatment: ALBUTEROL INHALER (AS NEEDED); CYANOCOBALAMIN; FOLIC ACID; NADOLOL ORAL; NAPROXEN ORAL; OCULAR LUBRICANT (OPHTH OINTMENT); ONDANSETRON (ZOFRAN) ORAL; ORAL LORATADINE
• Patient Age: 35 YR