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 2019-04-25 for ARCHITECT HBSAG CONFIRMATORY 09C94-25 manufactured by Abbott Ireland.
[145114584]
This event was previously reported in manufactures report 3008344661-2019-00028, however a second likely cause was added and this report is being submitted to document the second likely cause. 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
[145114585]
The customer observed a (b)(6) result on the architect i2000sr analyzer. The following data was provided for a (b)(6)-year old diagnosed with shingles: initial 3409 iu/ml, confirmation test (b)(6). The sample was confirmed (b)(6) at another laboratory. There was no impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008344661-2019-00054 |
| MDR Report Key | 8550019 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-04-25 |
| Date of Report | 2019-06-09 |
| Date Mfgr Received | 2019-06-05 |
| Device Manufacturer Date | 2018-09-25 |
| Date Added to Maude | 2019-04-25 |
| 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 CONFIRMATORY |
| Generic Name | HBSAG CONFIRMATORY |
| Product Code | KSJ |
| Date Received | 2019-04-25 |
| Catalog Number | 09C94-25 |
| Lot Number | 90315FN00 |
| Device Expiration Date | 2019-09-10 |
| 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 | 2019-04-25 |