ARCHITECT STAT MYOGLOBIN 02K43-25

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2011-11-17 for ARCHITECT STAT MYOGLOBIN 02K43-25 manufactured by Abbott Laboratories.

Event Text Entries

[18743380] Precision testing was performed using an in-house file kit of architect stat myoglobin (b)(4) reagent lot 22396un11. Precision testing results met the acceptance criteria. Customer complaint data was reviewed and no adverse trends were identified. The architect stat myoglobin reagent package insert was reviewed and was found to adequately address the issue. The investigation did not identify a product deficiency.
Patient Sequence No: 1, Text Type: N, H10


[21294743] The account stated that a low architect myoglobin result of 8. 3 ng/ml was generated. The sample was repeated after 2 hours and a result of 119. 8 ng/ml was generated. A second sample was obtained 2 hours later and a result of 112 ng/ml was generated. There was no report of impact to patient management.
Patient Sequence No: 1, Text Type: D, B5


[21517876] (b)(4). An investigation is in process. A follow-up report will be submitted when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1415939-2011-00687
MDR Report Key2341225
Report Source01,05
Date Received2011-11-17
Date of Report2011-11-02
Date of Event2011-10-28
Date Mfgr Received2012-01-11
Device Manufacturer Date2011-04-01
Date Added to Maude2011-12-14
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 LABORATORIES
Manufacturer Street100 ABBOTT PARK ROAD
Manufacturer CityABBOTT PARK IL 60064350
Manufacturer CountryUS
Manufacturer Postal Code60064 3500
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameARCHITECT STAT MYOGLOBIN
Product CodeDDR
Date Received2011-11-17
Catalog Number02K43-25
Lot Number22396UN11
Device Expiration Date2012-09-30
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerABBOTT LABORATORIES
Manufacturer Address100 ABBOTT PARK ROAD ABBOTT PARK IL 60064350 US 60064 3500


Patients

Patient NumberTreatmentOutcomeDate
10 2011-11-17

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