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 2017-09-22 for ARCHITECT I1000SR ANALYZER 01L86-01 manufactured by Abbott Manufacturing Inc.
[88222612]
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. This issue was previously reported under mdr number 3008344661-2017-00080 under a different suspect device.
Patient Sequence No: 1, Text Type: N, H10
[88222613]
The customer observed falsely elevated alpha-fetoprotein (afp) results while using the architect i1000 sr analyzer. The following data was provided. (b)(6). The patient is a child that was diagnosed with immature teratoma of the retroperitoneal space and was treated in 2015. The patient was being monitored after treatment of germogenic tumors. No adverse impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1628664-2017-00353 |
| MDR Report Key | 6887699 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-09-22 |
| Date of Report | 2017-10-05 |
| Date of Event | 2017-08-23 |
| Date Mfgr Received | 2017-10-04 |
| Device Manufacturer Date | 2012-04-01 |
| Date Added to Maude | 2017-09-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 MANUFACTURING INC |
| Manufacturer Street | 1921 HURD DRIVE |
| Manufacturer City | IRVING TX 75038 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75038 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARCHITECT I1000SR ANALYZER |
| Generic Name | AUTOMATED IMMUNOASSAY ANALYZER |
| Product Code | LOJ |
| Date Received | 2017-09-22 |
| Catalog Number | 01L86-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MANUFACTURING INC |
| Manufacturer Address | 1921 HURD DRIVE IRVING TX 75038 US 75038 |
| Brand Name | ARCHITECT I1000SR ANALYZER |
| Generic Name | AUTOMATED IMMUNOASSAY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-09-22 |
| Catalog Number | 01L86-01 |
| 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 MANUFACTURING INC |
| Manufacturer Address | 1921 HURD DRIVE IRVING TX 75038 US 75038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-22 |