ARCHITECT I2000SR ANALYZER 03M74-01

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2012-12-26 for ARCHITECT I2000SR ANALYZER 03M74-01 manufactured by Abbott Manufacturing Inc.

Event Text Entries

[3100046] The customer stated an architect i2000sr analyzer generated a (b)(6) result for one patient sample. The architect generated a (b)(6). The sample was retested on a vidas analyzer and a negative (b)(6) result was generated. The (b)(6) result was not reported outside the laboratory and there was no adverse impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5


[10385881] (b)(4). A follow up report will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10


[15276346] The customer stated an architect i2000sr analyzer generated a (b)(6) result for one patient sample. Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, and a review of labeling. Review of the message history found multiple liquid not found and aspiration errors for the sample pipettor. Replacement of the probe resolved the issue. Tracking and trending identified no adverse trends or non-statistical trends for the probe. Labeling was reviewed and found to be adequate. No product deficiency was identified.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1628664-2012-00516
MDR Report Key2885214
Report Source01
Date Received2012-12-26
Date of Report2012-12-07
Date of Event2012-12-06
Date Mfgr Received2013-01-10
Device Manufacturer Date2005-06-07
Date Added to Maude2013-01-09
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 Location0
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 Phone847937-512
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 Details

Brand NameARCHITECT I2000SR ANALYZER
Product CodeOMI
Date Received2012-12-26
Catalog Number03M74-01
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 2012-12-26

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