MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ID NOW INSTRUMENT

Catalog Number NAT024

Device Problem Overheating of Device (1437)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/13/2021

Event Type  malfunction  

Event Description

The customer reported their id now instrument started to smoke.There was no user injury reported.No further information was provided.

Manufacturer Narrative

The release documentation for instrument pn: nat-024 and instrument serial number (b)(4) was reviewed and the instrument met all release criteria.Upon receipt at abbott diagnostics (b)(4), the instrument was sent to the systems group for further investigation.Systems attempted to power on instrument and observed power was lost immediately after relay energized sending power to base board.Disassembled instrument to further investigate and observed capacitor c85 on base board had blown shorting out 12 volt power supply.C85 is a 16v capacitor in a 12v circuit and is adequately sized to operate under nominal operating conditions.16v capacitors in a 12v circuit are susceptible to damage if there is a voltage transient in the power supply.In a well designed circuit, capacitors should be rated for 2x the indented voltage used so it can easily handle any voltage transients.The materials surrounding the failing capacitor are either non-flammable (aluminum) or flammability rated with a minimum of 94v-2.These ratings are required for iec 61010-1 compliance.Iec 61010-1 compliance has been commissioned using tuv rheinland and tuv rheinland's safety mark is on the id now ratings label.In conclusion, the customer's returned instrument was verified to have a short when tested at abbott that may have caused smoking when tested at abbott diagnostics (b)(4).A root cause of the customers complaint is a shorted capacitor from a voltage spike above its rated voltage which is considered a design issue.Short caused instruments power pack to stop supplying power as an intended safety feature, preventing instrument from turning on.Abbott has implemented a change to increase the size of the capacitor to 25v, more then 2x operating voltage to better handle voltage transients.

• Brand Name: ID NOW INSTRUMENT
• Type of Device: ID NOW INSTRUMENT
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH, INC.; 10 southgate road; scarborough ME 04074
• MDR Report Key: 12438567
• MDR Text Key: 281843139
• Report Number: 1221359-2021-02560
• Device Sequence Number: 1
• Product Code: OOI
• UDI-Device Identifier: 00811877010593
• UDI-Public: 0100811877010593
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: NAT024
• Date Manufacturer Received: 08/13/2021
• Patient Sequence Number: 1