ARCHITECT I2000SR ANALYZER 03M74-02

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2017-05-17 for ARCHITECT I2000SR ANALYZER 03M74-02 manufactured by Abbott Manufacturing Inc.

Event Text Entries

[75445246] An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. (b)(6).
Patient Sequence No: 1, Text Type: N, H10


[75445247] The customer observed a false negative (b)(6) result while using the architect (b)(6) assay on the architect i2000sr analyzer. The customer indicated that a specimen that generated a negative result was retested at another laboratory and was positive using the chemiluminescence technique. Additionally, the customer indicated that 28 additional specimens were tested and generated negative results which were positive upon retest. No specific data has been provided. There was no impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1628664-2017-00220
MDR Report Key6573048
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2017-05-17
Date of Report2017-08-02
Date of Event2017-04-27
Date Mfgr Received2017-07-17
Date Added to Maude2017-05-17
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactNOEMI ROMERO-KONDOS, RN BSN
Manufacturer Street100 ABBOTT PARK ROAD DEPT. 09B9, LCCP1-3
Manufacturer CityABBOTT PARK IL 600643537
Manufacturer CountryUS
Manufacturer Postal600643537
Manufacturer Phone224667-512
Manufacturer G1ABBOTT MANUFACTURING INC
Manufacturer Street1921 HURD DRIVE
Manufacturer CityIRVING TX 75038
Manufacturer CountryUS
Manufacturer Postal Code75038
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Sequence Number: 0

Brand NameARCHITECT I2000SR ANALYZER
Generic NameAUTOMATED IMMUNOASSAY ANALYZER
Product CodeGMT
Date Received2017-05-17
Catalog Number03M74-02
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No0
Device Event Key0
ManufacturerABBOTT MANUFACTURING INC
Manufacturer Address1921 HURD DRIVE IRVING TX 75038 US 75038

Device Sequence Number: 1

Brand NameARCHITECT I2000SR ANALYZER
Generic NameAUTOMATED IMMUNOASSAY ANALYZER
Product CodeJJE
Date Received2017-05-17
Catalog Number03M74-02
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerABBOTT MANUFACTURING INC
Manufacturer Address1921 HURD DRIVE IRVING TX 75038 US 75038


Patients

Patient NumberTreatmentOutcomeDate
10 2017-05-17

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