A1-FETOPROTEIN (AFP) 04481798190

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2015-06-01 for A1-FETOPROTEIN (AFP) 04481798190 manufactured by Roche Diagnostics.

Event Text Entries

[5833515] The customer received questionable alpha1-fetoprotein (afp) results for one patient sample when compared to another methodology. The specific date of testing was not provided. The results from the cobas e601 analyzer serial number (b)(4) were 20- 21 ng/ml and were reproducible. These results did not match the patient's clinical condition. The result from a beckman access (unicell dxi) was <7 ng/ml. Information concerning which result was reported outside the laboratory was requested, but was not provided. No adverse event was reported.
Patient Sequence No: 1, Text Type: D, B5


[13407624] This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10


[32500322] A specific root cause could not be determined. Sample from the patient was tested as part of the investigation and the customer's results were reproduced and comparable on a cobas e411 and an abbott architect analyzer. As insufficient sample volume remained, no further investigation was possible. Differences in results between the two afp methods may be due to the different antibodies and technologies used. This information is documented in product labeling for the assay. Information was provided that the patient had a lung tumor. The use of the assay for monitoring of lung cancer patients is not an approved use.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1823260-2015-03554
MDR Report Key4808592
Report Source01,05,06
Date Received2015-06-01
Date of Report2015-06-22
Date of Event2015-05-13
Date Mfgr Received2015-05-13
Date Added to Maude2015-06-01
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 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 NameA1-FETOPROTEIN (AFP)
Generic NameALPHA-FETOPROTEIN FOR TESTICULAR CANCER
Product CodeLOJ
Date Received2015-06-01
Model NumberNA
Catalog Number04481798190
Lot NumberASKU
ID NumberNA
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 46250 US 46250


Patients

Patient NumberTreatmentOutcomeDate
10 2015-06-01

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