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 2020-03-26 for ARCHITECT I2000SR ANALYZER 3M74-02 03M74-88 manufactured by Abbott Laboratories (irving Ia/cc).
[185066645]
During the subsequent site visit by the field service engineer (fse) the analyzer was inspected and discovered that the architect vacuum pump was the likely cause due to the damaged vacuum pump capacitor. The vacuum pump was replaced by the fse which resolved the issue. A review of the service history for the architect isr01183 analyzer revealed no additional issues were reported. A review of tracking and trending did not identify any trends for the architect i2000sr or the architect vacuum pump. Labeling was reviewed and contains adequate information on troubleshooting, removal and replacement of the part. The damage observed was limited to a small area of the vacuum pump and the damage did not spread to other parts of the instrument. Based on the investigation, no product deficiency was identified.
Patient Sequence No: 1, Text Type: N, H10
[185066646]
The customer reported smoke emanating from the architect i2000sr analyzer from the left rear side facing the front. The customer powered off the analyzer. No injuries occurred due to this issue. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3016438761-2020-00013 |
| MDR Report Key | 9884061 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-03-09 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2003-09-18 |
| Date Added to Maude | 2020-03-26 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CHRISTIAN LEE |
| Manufacturer Street | 100 ABBOTT PARK ROAD DEPT 09B9, BLDG CP01-3 |
| Manufacturer City | ABBOTT PARK IL 600643537 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643537 |
| Manufacturer Phone | 224668-294 |
| Manufacturer G1 | ABBOTT LABORATORIES (IRVING IA/CC) |
| Manufacturer Street | 1915 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 | JJE |
| Date Received | 2020-03-26 |
| Model Number | 3M74-02 |
| Catalog Number | 03M74-88 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT LABORATORIES (IRVING IA/CC) |
| Manufacturer Address | 1915 HURD DRIVE IRVING TX 75038 US 75038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-26 |