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 2018-12-20 for ALINITY I FERRITIN 07P65-30 manufactured by A.i.d.d Longford.
[131796002]
A product recall letter was issued to customers who received shipments of the affected alinity reagents to inform them of the manufacturing issue identified with the reagent cartridge bottle necks. The letter instructs the customer to manually inspect each reagent cartridge in inventory before use. Stat assays, alinity i stat high sensitive troponin- i and alinity i total b-hcg, should be inspected first as a priority to ensure no delay in testing for those assays. Removals and corrections report number: 3005094123-11/21/18-002-r.
Patient Sequence No: 1, Text Type: N, H10
[131796003]
The customer observed error code 5662 (reagent transport failed to load reagent cartridge or rack in reagent carousel) while loading alinity i ferritin reagent lot 91532ui00 on the alinity i processing module. There was no report of any patient impact due to the potential delay in generating ferritin results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005094123-2018-00264 |
| MDR Report Key | 8187145 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-12-20 |
| Date of Report | 2018-12-20 |
| Date of Event | 2018-11-15 |
| Date Mfgr Received | 2018-12-06 |
| Device Manufacturer Date | 2018-10-01 |
| Date Added to Maude | 2018-12-20 |
| 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 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 3005094123-11/21/18-002R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALINITY I FERRITIN |
| Generic Name | FERRITIN |
| Product Code | DBF |
| Date Received | 2018-12-20 |
| Catalog Number | 07P65-30 |
| Lot Number | 91532UI00 |
| Device Expiration Date | 2019-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-12-20 |