MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-15 for ID NOW INSTRUMENT NAT024 manufactured by Abbott Diagnostics Scarborough, Inc..
[179443553]
Investigation was performed at abbott diagnostics scarborough, inc. On id now instrument pn: nat-024, serial number (b)(4). Observations indicated capacitor c85 on the baseboard was damaged and shorting out the 12v power supply. There is no risk of failure causing additional damage as the instrument is designed to cut all supplied power if the 12v power supply is shorted. All pcb boards and the cover housing are ul94v-0 rated. Ul94 is the standard for flammability of plastic materials and v-0 is of the highest rating. Manufacturing and release documentation was reviewed and the instrument met all release criteria. The product review risk for the reported electrical issue is anticipated in nature and severity for id now instrument according to the product risk management file. A review of the complaints reported as no power/blank display related to id now instrument pn: nat-024 serial number (b)(4) showed no other cases. The available evidence suggests that the instrument is performing as intended as the instrument failed safely as intended by design.
Patient Sequence No: 1, Text Type: N, H10
[179443554]
A customer reported a power issue and visible smoke with the id now instrument. The customer received the id now instrument on friday, (b)(6) 2019 and set it up the same day, with no report of using the instrument to run any samples. The customer returned to work on monday, (b)(6) 2019. The customer tried to power on the id now instrument but it would not turn on, and the customer observed smoke from the usb port. The instrument was unplugged from the power source. No other instruments were plugged into the same power source at the time of the event. The customer stated there was not a power outage over the weekend, although the customer noted the office light was on when they left on friday and was off when they returned to the office on monday. The event did not cause injury or death. No id now assay platforms were involved in the event, therefore there was no impact to patient testing. The customer returned the id now instrument to abbott diagnostics scarborough, inc. For investigation. Visible smoke is reported as a malfunction as there is potential for serious injury if the event were to recur.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221359-2020-00001 |
| MDR Report Key | 9591127 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-15 |
| Date of Report | 2020-01-13 |
| Date of Event | 2019-12-16 |
| Date Mfgr Received | 2019-12-16 |
| Device Manufacturer Date | 2019-05-29 |
| Date Added to Maude | 2020-01-15 |
| 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 | MRS. ERIN ROWLEY |
| Manufacturer Street | 10 SOUTHGATE ROAD |
| Manufacturer City | SCARBOROUGH ME 04074 |
| Manufacturer Country | US |
| Manufacturer Postal | 04074 |
| Manufacturer Phone | 2077305858 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ID NOW INSTRUMENT |
| Generic Name | ID NOW |
| Product Code | OOI |
| Date Received | 2020-01-15 |
| Returned To Mfg | 2019-12-23 |
| Catalog Number | NAT024 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT DIAGNOSTICS SCARBOROUGH, INC. |
| Manufacturer Address | 10 SOUTHGATE ROAD SCARBOROUGH ME 04074 US 04074 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-15 |