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.
[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
| Report Number | 3008344661-2019-00056 |
| MDR Report Key | 8557388 |
| 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 | 3 |
| 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 |