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 2017-05-17 for ARCHITECT I2000SR ANALYZER 03M74-02 manufactured by Abbott Manufacturing Inc.
[75445246]
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[75445247]
The customer observed a false negative (b)(6) result while using the architect (b)(6) assay on the architect i2000sr analyzer. The customer indicated that a specimen that generated a negative result was retested at another laboratory and was positive using the chemiluminescence technique. Additionally, the customer indicated that 28 additional specimens were tested and generated negative results which were positive upon retest. No specific data has been provided. There was no impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1628664-2017-00220 |
| MDR Report Key | 6573048 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-05-17 |
| Date of Report | 2017-08-02 |
| Date of Event | 2017-04-27 |
| Date Mfgr Received | 2017-07-17 |
| Date Added to Maude | 2017-05-17 |
| 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 I2000SR ANALYZER |
| Generic Name | AUTOMATED IMMUNOASSAY ANALYZER |
| Product Code | GMT |
| Date Received | 2017-05-17 |
| Catalog Number | 03M74-02 |
| 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 I2000SR ANALYZER |
| Generic Name | AUTOMATED IMMUNOASSAY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-05-17 |
| Catalog Number | 03M74-02 |
| 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 | 2017-05-17 |