MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-08 for ARCHITECT I2000SR ANALYZER 03M74-02 manufactured by Abbott Manufacturing Inc.
[35820024]
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
[35820025]
The customer stated that false positive architect bhcg results were generated for patient samples. No specific patient information or result data was provided. No adverse impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
[38887138]
After further evaluation, the suspect medical device was changed from architect i2000sr analyzer, list 03m74-02, manufacturing site irving, tx to architect total b-hcg reagent, list 07k78-25, manufacturing site lisnamuck, longford ireland. Mdr number 3005094123-2016-00009 has been submitted for the new suspect medical device and all further information will be documented under that mdr number. The suspect medical device changed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628664-2016-00009 |
| MDR Report Key | 5354833 |
| Date Received | 2016-01-08 |
| Date of Report | 2016-02-20 |
| Date of Event | 2015-11-26 |
| Date Mfgr Received | 2016-01-21 |
| Date Added to Maude | 2016-01-08 |
| 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 | NAL |
| Date Received | 2016-01-08 |
| Catalog Number | 03M74-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| 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 | 2016-01-08 |