MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ACCU-CHEK INFORM II; HANDHELD POWER SUPPLY

Catalog Number 05388805001

Device Problems Melted (1385); Smoking (1585)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/21/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer stated the power supply was smoking and melted.There were no signs of burning, melting, or smoking of the base unit or any of the meters.They unplugged the base and hooked up a new power supply.The base has been working acceptably for two weeks.The suspect base was requested to be returned for investigation.There was no adverse event.

Manufacturer Narrative

The suspect power supply was received for investigation.A visual investigation was performed and the prongs of the plug were damaged/burned.The charging function was tested using the returned power supply and a retention base unit, a meter, and a battery.The meter charged according to specifications and no smoke or melting was observed during or after charging.The prongs did not have any additional damage/burning.There was no unusual "warming up" during charging process observed.It was determined the product performed according to specification.

• Brand Name: ACCU-CHEK INFORM II
• Type of Device: HANDHELD POWER SUPPLY
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 7118396
• MDR Text Key: 95751054
• Report Number: 1823260-2017-02946
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071041
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05388805001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1