ARCHITECT HBSAG 06C36-34

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 2019-04-26 for ARCHITECT HBSAG 06C36-34 manufactured by Abbott Ireland.

Event Text Entries

[143388560] See also the other manufacturers reports for the other 5 patients: 3008344661-2019-00044, 3008344661-2019-00045, 3008344661-2019-00046, 3008344661-2019-00047, 3008344661-2019-00055. All available patient information was included. Additional patient details are not available. An evaluation is in process. A final report will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10


[143388561] The customer observed falsely elevated hbsag results on the architect i2000sr analyzer. The samples were repeatedly (b)(6); however, neutralizing confirmatory testing was not performed as required per the package insert. Unfortunately, 6 neonate patients were treated with unnecessary infusion of gamma globulin. The 6 neonates had all been inoculated with the (b)(6) vaccine prior to testing. The 6 patients treatment conditions were as follows: there were 3 patients where the condition was severe and required timely treatment. After discussions between the clinical physician and family members 2 patients underwent gamma globulin therapy, and 1 patient underwent plasma therapy. The other 3 patients underwent treatment by other treatment methods, but the specific treatment conditions are unknown. Of these, there were two patients who, after a new blood draw had a (b)(6) result for (b)(6) surface antigen. Roche confirmed the patients as (b)(6). Data and sid for the additional 2 patients were not provided. It was asked and not known which patient received which treatment. All known data has been provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3008344661-2019-00056
MDR Report Key8557388
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2019-04-26
Date of Report2019-05-21
Date Mfgr Received2019-05-21
Device Manufacturer Date2018-09-08
Date Added to Maude2019-04-26
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 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 IRELAND
Manufacturer StreetDIAGNOSTICS DIVISION FINISKLIN BUSINESS PARK
Manufacturer CitySLIGO NA
Manufacturer CountryEI
Manufacturer Postal CodeNA
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameARCHITECT HBSAG
Generic NameHBSAG
Product CodeKSJ
Date Received2019-04-26
Catalog Number06C36-34
Lot Number91049FN00
Device Expiration Date2019-08-24
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerABBOTT IRELAND
Manufacturer AddressDIAGNOSTICS DIVISION FINISKLIN BUSINESS PARK SLIGO NA EI NA


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-04-26

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