MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-09 for ARCHITECT HE4 02P54-25 manufactured by Abbott Germany.
[47944433]
Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of instrument logs, a review of labeling and accuracy testing. No adverse trend was identified for the customer's issue. Labeling was reviewed and found to be adequate. The product was not available for return. An internal panel was tested with retained kits of the likely cause reagent lot and accuracy testing met all specifications. Based on all available information and abbott diagnostics' complaint investigation, the assay performed as intended and no product deficiency was identified.
Patient Sequence No: 1, Text Type: N, H10
[47956963]
An evaluation is in process. A follow up report will be submitted when the evaluation is complete. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[47956964]
The customer observed a false negative he4 result on the architect i1000sr analyzer. The following data was provided: initial 47. 5, repeat 67. 3 pmol/l. There was no impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
[75119003]
The conclusion code was corrected to (b)(4). The device evaluation was reassessed and concluded that a malfunction occurred, therefore, the device was not performing as intended, however, no systemic issue or product deficiency was identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002809144-2016-00035 |
| MDR Report Key | 5710065 |
| Date Received | 2016-06-09 |
| Date of Report | 2017-05-09 |
| Date Mfgr Received | 2017-05-09 |
| Device Manufacturer Date | 2015-12-01 |
| Date Added to Maude | 2016-06-09 |
| 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 | ABBOTT GERMANY |
| Manufacturer Street | MAX-PLANCK-RING 2 |
| Manufacturer City | WIESBADEN 65205 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 65205 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARCHITECT HE4 |
| Generic Name | HE4 |
| Product Code | OIU |
| Date Received | 2016-06-09 |
| Catalog Number | 02P54-25 |
| Lot Number | 50440M500 |
| Device Expiration Date | 2016-10-05 |
| 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 GERMANY |
| Manufacturer Address | MAX-PLANCK-RING 2 WIESBADEN 65205 GM 65205 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-06-09 |