MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-05-09 for ARCHITECT B12 07K61-27 manufactured by A.i.d.d Longford.
[74762951]
Lot/serial number was manufactured prior to udi compliance date; therefore, only a di is provided an evaluation is in process. A follow-up report will be submitted when the evaluation is complete. H3 other text : an evaluation is in process.
Patient Sequence No: 1, Text Type: N, H10
[74762952]
The customer observed an elevated result while using the architect b12 assay. The customer provided the following data (pg/ml): sid (b)(4). Initial (b)(6) 2017: 522 retests: (b)(6) 2017: 303 and 4/15/17: 281.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005094123-2017-00020 |
| MDR Report Key | 6553872 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-05-09 |
| Date of Report | 2017-05-09 |
| Date of Event | 2017-04-13 |
| Date Mfgr Received | 2017-04-17 |
| Date Added to Maude | 2017-05-09 |
| 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 |
| 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 | A.I.D.D LONGFORD |
| Manufacturer Street | LISNAMUCK CO. LONGFORD |
| Manufacturer City | LONGFORD 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 B12 |
| Generic Name | VITAMIN B12 |
| Product Code | CDD |
| Date Received | 2017-05-09 |
| Catalog Number | 07K61-27 |
| Lot Number | 70399UI00 |
| Device Expiration Date | 2017-10-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | A.I.D.D LONGFORD |
| Manufacturer Address | LISNAMUCK CO. LONGFORD LONGFORD NA EI NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-09 |