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 2016-12-08 for ARCHITECT I2000SR ANALYZER 03M74-02 manufactured by Abbott Manufacturing Inc.
[61873230]
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[61873231]
The customer indicated that discrepant architect total psa results were generated. On (b)(6) 2016 a result of less than 0. 1 ng/ml was generated. On (b)(6) 2016 a result of 5. 8 ng/ml was generated. There was no report of impact to patient management.
Patient Sequence No: 1, Text Type: D, B5
[64471901]
The architect i2000sr analyzer was inspected by the laboratory's service technicians who discovered leaking from the tubing connection of the pre-trigger pump. The pre-trigger pump was replaced. There have been no additional occurences of discrepant results since the pre-trigger pump was replaced. Customer complaint data was reviewed and no systemic issues or adverse trends were identified. The architect systems operations manual and the architect total psa reagent package insert were reviewed and were found to adequately address the issue. The investigation did not identify a malfunction / deficiency.
Patient Sequence No: 1, Text Type: N, H10
[75946035]
The device evaluation was reassessed and concluded that a malfunction occurred, therefore, the device was not performing as intended at the customer site. However, no systemic issue and/or product deficiency was identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628664-2016-00299 |
| MDR Report Key | 6157140 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2016-12-08 |
| Date of Report | 2017-05-15 |
| Date of Event | 2016-11-11 |
| Date Mfgr Received | 2017-04-19 |
| Device Manufacturer Date | 2012-01-01 |
| Date Added to Maude | 2016-12-08 |
| 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 | LTZ |
| Date Received | 2016-12-08 |
| Catalog Number | 03M74-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2016-12-08 |
| Catalog Number | 03M74-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2016-12-08 |