MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ROCHE CARDIAC D-DIMER 10 TESTS (COBAS); FIBRINOGEN/FIBRIN DEGRADATION PRODUCTS ASSAY

Catalog Number 04877802190

Device Problem Low Test Results (2458)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 01/03/2014

Event Type  malfunction  

Event Description

The customer alleged they received questionable d-dimer results for one patient on their cobas h232 device, serial number (b)(4).The h232 meter is not sold in the united states.The patient had a plasma sample tested on a sysmex-cs 2100 analyzer at an external laboratory and the result was >1000 ug/l.The patient had a whole blood sample tested in the doctor's office on the h232 meter and the result was 0.53 ug/ml.The patient had a whole blood sample tested in the doctor's office on the h232 meter and the result was 0.60 ug/ml.Information on whether the results from the h232 meter were from the same sample was requested but not provided.The customer stated "blood sample for the external laboratory was taken 10 minutes before the first blood taken".Information on whether any of the results were reported outside the laboratory was requested but not provided.Information on whether the patient was adversely affected was requested but not provided.An investigation was performed on retention d-dimer strips from lot number 28159610 tested on a qualified h232 meter.The results of all the measurements fulfilled the requirements.

Manufacturer Narrative

This event occurred in (b)(6).

Manufacturer Narrative

A definitive root cause could not be determined.The customer returned the h232 device and a box containing three un-used test strips from lot 28159615.The customer's test strips and retention strips from lot 28159610 were tested on the returned h232 and a qualified h232.All the results fulfilled the requirements.

Manufacturer Narrative

Additional information has been provided by the customer.The patient's initial result from the sysmex analyzer was 1173 ug/l.The patient's third result was actually 0.576 ug/ml.All of the results were reported outside the laboratory.The patient was not adversely affected by this event.

• Brand Name: ROCHE CARDIAC D-DIMER 10 TESTS (COBAS)
• Type of Device: FIBRINOGEN/FIBRIN DEGRADATION PRODUCTS ASSAY
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 6830 5; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 3602051
• MDR Text Key: 4094716
• Report Number: 1823260-2014-00680
• 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,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04877802190
• Device Lot Number: 28159610
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 01/07/2014
• 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
• Patient Sequence Number: 1
• Treatment: PANTOPRAZOL; MOTILIUM; TEMESTA; MIMPARA; RESONIUM; COLOSAN MITE CITRON GRAN; CALCIUM AC; FERINJECT; DIALVIT CAPS; DILATREND; APROVEL; ADALAT; ARANESP; ULCOGANT; SORTIS 40; RENVELA; DAFALGAN; SERETIDE 250 DISKUS; BUSCOPAN; CARNITENE
• Patient Age: 034 YR