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

Catalog Number 04625315160

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/03/2015

Event Type  malfunction  

Event Description

The trainer reported that while training the customer a result of 3.9 inr compared to a result of 5.3 inr on the same coaguchek xs meter (serial number (b)(4)) were obtained 10 minutes apart.Each test was from a different finger.The meter belonged to the customer and the strips were the trainer's professional strips.The customer's therapeutic range is 2.0 inr to 3.0 inr.There was not any medical treatment given or change made to the customer's coumadin dose.There was not an adverse event.There was not any special or unusual diet consumed by the customer prior to the results.The customer did not show any symptoms of a high inr at the time of the testing.The suspect product was requested to be returned and replacement product was sent.

• 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) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 5221317
• MDR Text Key: 31075199
• Report Number: 1823260-2015-04536
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 02/29/2016
• Device Catalogue Number: 04625315160
• Device Lot Number: 20513611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2015
• Initial Date FDA Received: 11/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: ATORVASTATIN (>5 YEARS)
• Patient Age: 090 YR
• Patient Weight: 49