MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-27 for ARCHITECT I1000SR ANALYZER 01L86-40 manufactured by Abbott Manufacturing Inc.
[46204249]
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
[46204250]
The customer reports false positive architect total b-hcg assay results generated on an architect i1000sr analyzer. The following examples were provided: (b)(6): 31. 40 and less than 1. 20 miu/ml ((b)(6) 2016). (b)(6): 52. 24 and less than 1. 20 miu/ml ((b)(6) 2016). No suspect results were reported from the lab. There is no reported impact to patient management.
Patient Sequence No: 1, Text Type: D, B5
[46323004]
An abbott field service engineer (fse) went onsite to inspect the architect i1000sr analyzer and proactively replaced five manifold kit valves on the wash zones and three trigger/pre-trigger 2-way bypass valves as well as the pipettor probe. Subsequent instrument operations were acceptable. A review of complaint tracking and trending metrics was performed and identified no adverse trends in conjunction with the complaint issue currently under evaluation. The architect system operations manual and the architect total b-hcg assay package insert both contain information to address the current customer issue. Based on the available information from the customer site and from the results of this evaluation, there is no evidence to reasonably suggest a product malfunction occurred. The issue was addressed through standard troubleshooting procedures.
Patient Sequence No: 1, Text Type: N, H10
[72900616]
The device evaluation was reassessed and concluded that a malfunction occurred; therefore, the device was not performing as intended and the evaluation codes were corrected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628664-2016-00138 |
| MDR Report Key | 5686460 |
| Date Received | 2016-05-27 |
| Date of Report | 2017-04-15 |
| Date Mfgr Received | 2017-04-07 |
| Device Manufacturer Date | 2010-06-01 |
| Date Added to Maude | 2016-05-27 |
| 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 I1000SR ANALYZER |
| Generic Name | AUTOMATED IMMUNOASSAY ANALYZER |
| Product Code | NAL |
| Date Received | 2016-05-27 |
| Catalog Number | 01L86-40 |
| 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 I1000SR ANALYZER |
| Generic Name | AUTOMATED IMMUNOASSAY ANALYZER |
| Product Code | JJE |
| Date Received | 2016-05-27 |
| Catalog Number | 01L86-40 |
| 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 | 2016-05-27 |