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

Catalog Number 04877802190

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/19/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer stated that they received an erroneous result for one patient sample tested for roche cardiac d-dimer (ddi) on a cobas h 232 analyzer at the doctor's office.The cobas h 232 analyzer is not sold in the united states, nor is it like or similar to a product sold in the united states.A lithium heparin whole blood tube was measured on the cobas h 232 analyzer within one hour of collection and the result was 0.48 ug/ml.The control line was visible on the test strip.A sodium citrate tube collected at the same time was tested on a stago compact instrument in a different laboratory on (b)(6) 2016 and the result was 1100 ug/l.The 1100 ug/l result was believed to be correct since the customer expected a higher value from the cobas h 232 analyzer.The patient was not adversely affected.The cobas h 232 analyzer serial number was (b)(4).Control recovery on the cobas h 232 analyzer was ok.The customer's product has been requested for investigation.Relevant retention material # 17668510 was measured on a qualified cobas h 232 analyzer with two native blood samples and two spiked blood samples (c=0.80 ug/ml and c=2.20 ug/ml).Each blood sample was measured on three test strips.Results: mean of the measurements on a qualified cobas h 232 analyzer: first native blood sample: 0.27 ug/ml.Second native blood sample: 0.33 ug/ml.First spiked blood sample (c=0.80 ug/ml): 0.76 ug/ml.Second spiked blood sample (c=2.20 ug/ml): 2.10 ug/ml.The results of all measurements fulfill requirements.

Manufacturer Narrative

The customer's test strips and cobas h 232 analyzer were returned for investigation.The temperature requirements for the test strips were not met during shipment.Test strips from customer lot number were measured on the cobas h232 analyzer from the customer and on a qualified cobas h232 with one native blood sample and one spiked blood sample (c=1.00 ug/ml).Each blood sample was measured twice on the cobas h232 analyzer from the customer and on the qualified cobas h232 analyzer.Mean of measurements on the cobas h232 analyzer from the customer: native blood sample: 0.19 ug/ml.Spiked blood sample (c=1.00 ug/ml): 0.96 ug/ml.Mean of measurements on the qualified cobas h232 analyzer: native blood sample: 0.19 ug/ml.Spiked blood sample (c=1.00 ug/ml): 0.96 ug/ml.The results of all measurements fulfill requirements.

• Brand Name: ROCHE CARDIAC D-DIMER
• Type of Device: FIBRINOGEN AND 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: 6232287
• MDR Text Key: 64133101
• Report Number: 1823260-2017-00036
• Device Sequence Number: 1
• Product Code: DAP
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K033491
• 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: 02/01/2017

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 Expiration Date: 09/30/2017
• Device Catalogue Number: 04877802190
• Device Lot Number: 17668511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2016
• Initial Date FDA Received: 01/09/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/01/2017
• 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: ASPIRIN CARDIO; ELTROXIN; MAGNESION; MOLAXOL (WHEN NECESSARY); SPRIVA; SYMBICORT; TORASEMID SANDOX; VITAMIN D3
• Patient Age: 74 YR