MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2014-06-26 for ARCHITECT I2000SR ANALYZER 03M74-01 manufactured by Abbott Manufacturing Inc.
[18934404]
The customer stated that a (b)(6) result of (b)(6) was generated. The sample was repeated multiple times with results in the range of (b)(6). The patient had been run on another analyzer with a (b)(6) result. There was no report of impact to patient management.
Patient Sequence No: 1, Text Type: D, B5
[19134203]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[32678757]
A false negative anti hbc result was generated for one patient on the architect i2000sr analyzer. Field service performed troubleshooting and determined the probable cause was the wash buffer dispense at the wash zones was inadequate. Service replaced the valve manifold kits to resolve the issue. No further discrepant results were noted. Customer complaint data was reviewed and no adverse trends were identified. The architect system operations manual was reviewed and was found to adequately address the issue. The investigation did not identify a malfunction / deficiency.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628664-2014-00124 |
| MDR Report Key | 3897760 |
| Report Source | 01,05 |
| Date Received | 2014-06-26 |
| Date of Report | 2014-06-02 |
| Date Mfgr Received | 2014-07-03 |
| Device Manufacturer Date | 2003-02-20 |
| Date Added to Maude | 2014-07-17 |
| 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 | 0 |
| Event Location | 0 |
| 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 | 847937-512 |
| 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 | MZP |
| Date Received | 2014-06-26 |
| Catalog Number | 03M74-01 |
| 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 | 2014-06-26 |