IGG-2 TINA-QUANT IGG GEN.2 03507432190

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-10-16 for IGG-2 TINA-QUANT IGG GEN.2 03507432190 manufactured by Roche Diagnostics.

Event Text Entries

[90572620] Unique identifier (udi)#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[90572621] The customer stated that they received an erroneous result for one patient sample tested for igg-2 tina-quant igg gen. 2 (igg) on a cobas 6000 c (501) module - c501. An aliquot of the sample which was processed on a cobas p 612 pre-analytics system, initially resulted as 300 mg/dl accompanied by a data flag. The sample was repeated, resulting as 565 mg/dl and this value was reported outside of the laboratory. The physician asked for a repeat of the sample since the patient had a high result of 3248 mg/dl in (b)(6) 2016. The primary tube of the sample was repeated on (b)(6) 2017, resulting as 3982 mg/dl. The repeat result was believed to be correct. The patient was not adversely affected. The c501 analyzer serial number was (b)(4). The field service engineer could not determine a cause and stated that there may have possibly been sample preparation errors. He repeated the primary tube of the sample twice and the results replicated consecutively. He checked all rinse mechanism functions and these were within specifications. After customer maintenance of the analyzer, calibration and quality controls were run and passed within specifications. He ran precision studies and these were within specifications. The system was fully operational. The patient is diagnosed with monoclonal gammopathy. The field application specialist stated that the sample may have contained an interferent to the igg assay based on the patient's diagnosis.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1823260-2017-02330
MDR Report Key6951875
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2017-10-16
Date of Report2017-11-02
Date of Event2017-09-27
Date Mfgr Received2017-10-02
Date Added to Maude2017-10-16
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
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 NameIGG-2 TINA-QUANT IGG GEN.2
Generic NameIGG, ANTIGEN
Product CodeDEW
Date Received2017-10-16
Model NumberNA
Catalog Number03507432190
Lot Number24242601
ID NumberNA
Device Expiration Date2019-02-28
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 2017-10-16

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