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.
[143396254]
See also the other manufacturers reports for the other 5 patients: 3008344661-2019-00044, 3008344661-2019-00045, 3008344661-2019-00046, 3008344661-2019-00047, 3008344661-2019-00056. 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
[143396255]
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
| Report Number | 3008344661-2019-00055 |
| MDR Report Key | 8557396 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-04-26 |
| Date of Report | 2019-05-21 |
| Date Mfgr Received | 2019-05-21 |
| Device Manufacturer Date | 2018-09-08 |
| Date Added to Maude | 2019-04-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NOEMI ROMERO-KONDOS, RN BSN |
| Manufacturer Street | 100 ABBOTT PARK ROAD DEPT. 09B9, LCCP1-3 |
| Manufacturer City | ABBOTT PARK IL 600643537 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643537 |
| Manufacturer Phone | 224667-512 |
| Manufacturer G1 | ABBOTT IRELAND |
| Manufacturer Street | DIAGNOSTICS DIVISION FINISKLIN BUSINESS PARK |
| Manufacturer City | SLIGO NA |
| Manufacturer Country | EI |
| Manufacturer Postal Code | NA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARCHITECT HBSAG |
| Generic Name | HBSAG |
| Product Code | KSJ |
| Date Received | 2019-04-26 |
| Catalog Number | 06C36-34 |
| Lot Number | 91049FN00 |
| Device Expiration Date | 2019-08-24 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT IRELAND |
| Manufacturer Address | DIAGNOSTICS DIVISION FINISKLIN BUSINESS PARK SLIGO NA EI NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-26 |