MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK ® XS SYSTEM; PROTHROMBIN TIME TEST STRIPS

Catalog Number 04625315003

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Fever (1858)

Event Date 04/20/2015

Event Type  Injury  

Event Description

After having performed a test with the coaguchek xs system at home with a result of 2.2 inr, customer felt uncomfortable, had a temperature and aching limbs.Because of how the customer felt, customer was taken to the hospital by her husband and a lab draw was done approximately 2.5 hours after the meter test with a result of 1.1 inr.After lab result was returned, customer was treated with clexane.Requested return of suspect device.

Manufacturer Narrative

The event occurred in (b)(6).While this product is not sold in the united states, it is like or similar to a product marketed in the united states.

• Brand Name: COAGUCHEK ® XS SYSTEM
• Type of Device: PROTHROMBIN TIME TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 6830 5; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 4775516
• MDR Text Key: 5796836
• Report Number: 1823260-2015-03466
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 05/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2013
• Device Catalogue Number: 04625315003
• Device Lot Number: 23195011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2015
• Is the Reporter a Health Professional?: No
• Event Location: Home
• Date Manufacturer Received: 04/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATOSIL DROPS; WARFARIN; ARICLAIM 60 MG
• Patient Outcome(s): Hospitalization
• Patient Age: 051 YR