C-REACTIVE PROTEIN (LATEX) 20764930322

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-06-17 for C-REACTIVE PROTEIN (LATEX) 20764930322 manufactured by Roche Diagnostics.

Event Text Entries

[2083124] The user experienced calibration errors and flagged results for patient samples from the integra 800 analyzer serial number (b)(4). The user repeated testing of the patient samples on the other integra 800 analyzer serial number (b)(4). Of the data provided, the c-reactive protein result for one patient sample was discrepant and reported outside the laboratory. The initial result was 11. 66 mg/l and the repeat result was 50. 86 mg/l. The patients were not adversely affected. Upon evaluation of the analyzer, the field service representative determined there was a defective and disconnected level sense cable. He replaced the liquid level sense cable, worn ropes and a bent probe. He connected the valve cable above the transfer arm to the reagent module body. To verify the analyzer operation, he ran performance testing and the user ran and verified quality control.
Patient Sequence No: 1, Text Type: D, B5


[9017072] Additional assays involved in this event are reported on the medwatch forms patient identifiers (b)(6).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1823260-2011-03323
MDR Report Key2132767
Report Source05,06
Date Received2011-06-17
Date of Report2011-06-17
Date of Event2011-05-31
Date Mfgr Received2011-06-01
Date Added to Maude2011-06-17
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 FDA0
Event Location3
Manufacturer ContactNA RAE ANN FARROW
Manufacturer Street9115 HAGUE ROAD NA
Manufacturer CityINDIANAPOLIS IN 46250
Manufacturer CountryUS
Manufacturer Postal46250
Manufacturer Phone3175213194
Manufacturer G1ROCHE DIAGNOSTICS GMBH
Manufacturer StreetSANDHOFERSTRASSE 116 NA
Manufacturer CityMANNHEIM (BADEN-WURTTEMBERG) 68300
Manufacturer Postal Code68300
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameC-REACTIVE PROTEIN (LATEX)
Generic NameSYSTEM, TEST, C-REACTIVE PROTEIN
Product CodeDCN
Date Received2011-06-17
Model NumberNA
Catalog Number20764930322
Lot Number63367001
ID NumberNA
Device Expiration Date2012-08-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerROCHE DIAGNOSTICS
Manufacturer Address9118 HAGUE ROAD NA INDIANAPOLIS IN 46250 US 46250


Patients

Patient NumberTreatmentOutcomeDate
10 2011-06-17

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