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 2018-09-14 for ARCHITECT B12 07K61-35 manufactured by A.i.d.d Longford.
[120561511]
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. This report is being filed on an international product, list number 7k61-25 / 35 that has a similar product distributed in the us, list number 7k61-27 / 37. This issue was also reported under mdr number 1628664-2018-01883 for the analyzer.
Patient Sequence No: 1, Text Type: N, H10
[120561512]
The customer observed falsely elevated results while using architect b12 reagents. The following data was provided. Sid (b)(6) initial 298 pmol/l, repeat 221 pmol/l, sid (b)(6) initial 415 pmol/l, repeat 219 pmol/l, sid (b)(6) initial 230 pmol/l, repeat 157 pmol/l, sid (b)(6) initial 376 pmol/l, repeat 214 pmol/l, sid (b)(6) initial 370 pmol/l, repeat 221 pmol/l, sid (b)(6) initial 239 pmol/l, repeat 133 pmol/l. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005094123-2018-00050 |
| MDR Report Key | 7879520 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-09-14 |
| Date of Report | 2018-10-25 |
| Date of Event | 2018-08-23 |
| Date Mfgr Received | 2018-10-03 |
| Date Added to Maude | 2018-09-14 |
| 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 | 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 | 2018-09-14 |
| Catalog Number | 07K61-35 |
| Lot Number | 88078UI00 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2018-09-14 |