MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-11-01 for PRISM 6 CHANNEL ANALYZER 06A36-04 manufactured by Abbott Manufacturing Inc.
[91455699]
This information was previously reported in 1415939-2017-00008, however a correction in the manufacturer report number was needed, the mistake was identified on 1 november 2017. Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of instrument logs, a review of labeling and instrument service. No adverse trend was identified for the customer's issue. Labeling was reviewed and found to be adequate. The issue was resolved through standard troubleshooting procedures. The field service engineer (fse) reported that the abbott prism xy axis controller assembly, catalog number 1-51110-03, failed at first use, emitting smoke from the area of the x axis motor board within the assembly. The prism instrument (s/n (b)(4)) was powered off and the smoke dissipated. The x axis motor board was then replaced with a new x axis motor board. The new x axis motor board abbott prism xy gantry motor controller, catalog number 1-900445-01, also failed at first use emitting smoke. The prism instrument was powered off again and the smoke dissipated. The issue was resolved at the customer site by replacing the abbott prism xy axis controller assembly (1-51110-03). Based on all available information and abbott diagnostics' complaint investigation no product deficiency was identified.
Patient Sequence No: 1, Text Type: N, H10
[91455700]
An abbott field service engineer stated that upon installing a new xy axis controller assembly on prism analyzer serial (b)(4), a small stream of visible smoke was observed coming from the x axis motor board within the xy controller assembly. The prism was powered off. The smoke was isolated to the x axis motor board card cage and dissipated after the prism was powered off. The engineer replaced the x axis motor board (part 1-900445-01). But once again a small stream of smoke was observed and the prism was powered off. No fire was observed. No injuries occurred. The engineer replaced the xy controller assembly to resolve the issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1628664-2017-00408 |
| MDR Report Key | 6995022 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-11-01 |
| Date of Report | 2017-11-01 |
| Date of Event | 2017-01-11 |
| Date Mfgr Received | 2017-11-01 |
| Device Manufacturer Date | 2013-09-01 |
| Date Added to Maude | 2017-11-01 |
| 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 | PRISM 6 CHANNEL ANALYZER |
| Generic Name | AUTOMATED IMMUNOASSAY ANALYZER |
| Product Code | MZA |
| Date Received | 2017-11-01 |
| Catalog Number | 06A36-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2017-11-01 |