ROCHE CARDIAC D-DIMER 04877802190

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2016-08-05 for ROCHE CARDIAC D-DIMER 04877802190 manufactured by Roche Diagnostics.

Event Text Entries

[51345477] This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10


[51345478] 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. 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 sample from the patient was tested for ddi on the cobas h232 analyzer in the doctor's office and the result from this sample was 1. 1 ug/ml. The 1. 1 ug/ml result was reported outside of the laboratory. The patient was then transferred to the hospital based on the result. At the hospital, a sample from the patient was tested on a c501 analyzer, resulting as < 0. 15 ug/ml. The patient was not adversely affected. The cobas h 232 analyzer serial number was (b)(4).
Patient Sequence No: 1, Text Type: D, B5


[52790646] The customer provided the analyzer and test strips for investigation. Investigations were performed with the customer material and retention materials. Upon receipt of the customer material, it was found that temperature requirements for the sent test strips were not met. Investigation results fulfilled all requirements. The investigated material could be ruled out as a root cause. A handling issue or a sample interference issue could not be excluded out as potential root causes.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1823260-2016-01122
MDR Report Key5851368
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2016-08-05
Date of Report2016-08-16
Date of Event2016-07-20
Date Mfgr Received2016-07-21
Date Added to Maude2016-08-05
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactNA MICHAEL LESLIE
Manufacturer Street9115 HAGUE ROAD NA
Manufacturer CityINDIANAPOLIS IN 46250
Manufacturer CountryUS
Manufacturer Postal46250
Manufacturer Phone3175214343
Manufacturer G1ROCHE DIAGNOSTICS GMBH
Manufacturer StreetSANDHOFERSTRASSE 116 NA
Manufacturer CityMANNHEIM (BADEN-WURTTEMBERG) 68305
Manufacturer CountryGM
Manufacturer Postal Code68305
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameROCHE CARDIAC D-DIMER
Generic NameFIBRINOGEN AND FIBRIN SPLIT PRODUCTS
Product CodeDAP
Date Received2016-08-05
Model NumberNA
Catalog Number04877802190
Lot Number12155712
ID NumberNA
Device Expiration Date2017-02-28
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerROCHE DIAGNOSTICS
Manufacturer Address9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457


Patients

Patient NumberTreatmentOutcomeDate
10 2016-08-05

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.