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 2016-02-02 for ARCHITECT I2000 ANALYZER 08C89-01 manufactured by Abbott Manufacturing Inc.
[37341782]
(b)(4). A follow-up report will be submitted when the evaluation is complete. An evaluation is in-process.
Patient Sequence No: 1, Text Type: N, H10
[37341783]
The customer observed a falsely elevated afp result for one patient while using the architect i2000 analyzer. The following data was provided (ng/ml). (b)(6) 2016: initial 127. 10, retests 2. 70, 2. 40 and 2. 40. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
[38764133]
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 instrument service. No adverse trend was identified for the customer's issue. Labeling was reviewed and found to be adequate. The issue was resolved through standard troubleshooting procedures. Based on all available information and abbott diagnostics' complaint investigation, the analyzer performed as intended and no product deficiency was identified.
Patient Sequence No: 1, Text Type: N, H10
[74623636]
Conclusion code changed from 71 to 75. The device evaluation was reassessed and concluded that a malfunction occurred. However, no systemic issue or product deficiency was identified for the architect i2000 analyzer, list number 08c89.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628664-2016-00027 |
| MDR Report Key | 5404284 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2016-02-02 |
| Date of Report | 2017-04-23 |
| Date of Event | 2016-01-15 |
| Date Mfgr Received | 2017-04-18 |
| Device Manufacturer Date | 1999-09-28 |
| Date Added to Maude | 2016-02-02 |
| 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 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 I2000 ANALYZER |
| Generic Name | AUTOMATED IMMUNOASSAY ANALYZER |
| Product Code | CDZ |
| Date Received | 2016-02-02 |
| Catalog Number | 08C89-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 I2000 ANALYZER |
| Generic Name | AUTOMATED IMMUNOASSAY ANALYZER |
| Product Code | JJE |
| Date Received | 2016-02-02 |
| Catalog Number | 08C89-01 |
| 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 | 2016-02-02 |