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

Catalog Number 04625374160

Device Problem Inaccurate Information (4051)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/24/2019

Event Type  malfunction  

Manufacturer Narrative

Retention materials were visually investigated.For strip lot 32264421 the printed strip code number was verified to be 364.The investigation is currently ongoing.Occupation: occupation ni equals lay user/family member.

Event Description

The initial reporter received two error messages while trying to perform testing on their coaguchek xs meter serial number (b)(4).While troubleshooting the issue, the customer reported a labeling issue that could potentially impact patient results.The customer stated that for strip lot 32264421 the label is printed clearly and shows strip code 364.For strip lot 32264421, the correct strip code is 335.Product labeling states "each box of test strips comes with its own code chip.The code chip provides the meter with information such as the lot number and expiration date of the test strips.Before each test, make sure the correct code chip is in the meter.Each time you open a new box of test strips, replace the old code chip with the new one." product labeling states that when performing a test "slide the test strip into the test strip guide in the direction of the arrows until it stops.The meter turns on.The code number of the inserted code chip flashes on the display.Confirm that the number displayed matches the number on the test strip container." the customer could not recall what strip code number was displayed on the meter when using strip lot 32264421.There was no allegation of any incorrect results.There was no allegation of an adverse event.The customer also mentioned having a vial of strip lot 36887121.Strip code number 364 is correct for this lot.The test strip vial has been requested for return.

• Brand Name: COAGUCHEK ® XS SYSTEM
• Type of Device: PROTHROMBIN TIME TEST STRIPS
• 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: 8711877
• MDR Text Key: 148415388
• Report Number: 1823260-2019-02244
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/19/2019

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: Lay User/Patient
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 04625374160
• Device Lot Number: 32264421
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/24/2019
• Initial Date FDA Received: 06/19/2019
• 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