MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK XS SYSTEM; HANDHELD POWER SUPPLY

Catalog Number 04805666001

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/14/2017

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi)#: (b)(4).This event occurred in (b)(6).

Event Description

The customer stated that the handheld power supply, coaguchek xs plus meter, and handheld base unit were moved from their usual room to another room in the facility.The meter was docked in the base unit, and the power supply was connected to the base unit.The power supply was then plugged into the wall outlet and immediately began to visibly spark, smoke, and emit a burned smell.Power was lost to half of the building at the same time and the phone lines went down.There was no obvious damage to the meter or base unit.No adverse event occurred.No facility staff were harmed and no patients were involved.The power supply, meter, and base unit were returned for investigation.Replacement was sent.

Manufacturer Narrative

The power cord, power supply, meter and meter base unit were returned for investigation.Power cord functionally was tested.The power supply connector had a voltage of 7.67 v, and the green led was active.The power cord did not burn or smell burned, it was not hot, and there was no indication of flame or sparks.The meter and base unit functioned correctly with the power supply.The customer material met specifications and the complaint could not be reproduced.

• Brand Name: COAGUCHEK XS SYSTEM
• 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: 6677173
• MDR Text Key: 78728458
• Report Number: 1823260-2017-01368
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K071041
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04805666001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2017
• 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