MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-04 for ALERE AFINION ACR CONTROL 1115239 manufactured by Alere Technologies As.
[107732355]
Customer complaints regarding alere afinion acr control with out of range albumin values have been reported. The customer complaints are related to two afinion acr control c i lots and two afinion control c ii lots which are components of three different kit lots of afinion acr control. Internal investigation has revealed an error in the albumin target setting of the control lots involved in the complaints. Control c i and control c ii lot numbers, expiry dates, target values and acceptable ranges for albumin and creatinine are stated on a label on the front page of the alere afinion acr control package insert. The incorrect target values and acceptable ranges stated in the package insert for the affected afinion acr control lots is regarded as mislabelling. The affected lots are manufactured in november 2017 and january 2018 and distributed to customers in (b)(4) in the period (b)(4) 2017 - (b)(4) 2018. The remaining kits from the affected lots in the manufacturer's warehouse and with the distributors have been put on quality hold and will be discarded. The incident is regarded as mislabeling and field corrective actions have been initiated. A fsn will be distributed to all customers who have received kits from the affected lots. The mislabeled kits at the customers' sites will be replaced with alere afinion acr control kits from a new lot with correctly assigned target values.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003045237-2018-00002 |
| MDR Report Key | 7486430 |
| Date Received | 2018-05-04 |
| Date of Report | 2018-04-20 |
| Date Mfgr Received | 2018-03-22 |
| Device Manufacturer Date | 2017-11-14 |
| Date Added to Maude | 2018-05-04 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS MONICA VALLESTAD |
| Manufacturer Street | KJELSAASVEIEN 161 |
| Manufacturer City | OSLO, OSLO 1884 |
| Manufacturer Country | NO |
| Manufacturer Postal | 1884 |
| Manufacturer G1 | ALERE TECHNOLOGIES AS |
| Manufacturer Street | KJELSAASVEIEN 161 |
| Manufacturer City | OSLO, OSLO 1884 |
| Manufacturer Country | NO |
| Manufacturer Postal Code | 1884 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ALERE AFINION ACR CONTROL |
| Generic Name | ACR CONTROL |
| Product Code | JJY |
| Date Received | 2018-05-04 |
| Model Number | 1115239 |
| Catalog Number | 1115239 |
| Lot Number | 10193871, 10195065 |
| Device Expiration Date | 2019-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALERE TECHNOLOGIES AS |
| Manufacturer Address | KJELSAASVEIEN 161 OSLO, OSLO 0884 NO 0884 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-04 |