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 2017-04-28 for ARCHITECT I2000SR ANALYZER 03M74-96 manufactured by Abbott Manufacturing Inc.
[74148877]
This issue was previously reported under mdr number 3002809144-2017-00008 under a different suspect device. The customer complained of a single (b)(6) result generated on the architect (b)(4). Upon a site visit the field service engineer (fse) performed troubleshooting of the wash zone pressure check. The fse replaced a total of six manifold kit valves (part number 7-77612-03) for both wz1 and wz2. There have been no subsequent contacts from the customer regarding discrepant results since the fse replaced the wash zone manifold kit valves. The architect system operations manual provides information for troubleshooting the reported issue; and limitations of result interpretation. The architect syphilis package insert provides information for sample handling, performance characteristics, and interpretation of results. A search for similar complaints identified no trend of the manifold kit valve. A review of the i2000sr tracking and trending data revealed no systemic issues or trends associated with the erratic result described in this complaint. A malfunction was identified as the device failed to meet performance specifications or otherwise perform as intended at the customer site. However, a systemic issue and/or product deficiency was not identified. Complete information for section (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[74148878]
The customer stated that the archiyect analyzer generated a (b)(6) result on one patient. The results provided were: sid (b)(6)=initial 0. 09 s/co (<1. 00s/co = nonreactive) / repeat = 2. 35 / 2. 58s/co (>/=1. 00 s/co = reactive). There was no reported impact to patient management. There was no additional patient information provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1628664-2017-00154 |
| MDR Report Key | 6529720 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-04-28 |
| Date of Report | 2017-04-28 |
| Date of Event | 2017-01-26 |
| Date Mfgr Received | 2017-04-20 |
| Device Manufacturer Date | 2004-02-06 |
| Date Added to Maude | 2017-04-28 |
| 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 | 2017-04-28 |
| Catalog Number | 03M74-96 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2017-04-28 |
| Catalog Number | 03M74-96 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2017-04-28 |