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

Catalog Number ASKU

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/10/2015

Event Type  malfunction  

Manufacturer Narrative

The event occurred in (b)(6).

Event Description

The customer reported that on the same patient a result of 3.8 inr and then a result of 2.8 inr was obtained using the coaguchek xs (serial number (b)(4)).Separate punctures on different fingers were used to obtain these results.There are no further details provided regarding the patient or any medication changes based on the results.The customer also reported getting an error 6 message on multiple patients on the same device.The customer also noted that they believe this strip batch works fine in other meters.There was no adverse event.The suspect product was requested to be returned and the replacement product was sent.The relevant retention test strips (lot 205400-10) were tested in comparison with the current master lot coaguchek xs pt test strip (lot 230 734 80).No error messages occurred and the retention samples were inconspicuous.The retention material performed as specified.

Manufacturer Narrative

The customer returned one vial of test strip lot 205400-13 (vial no.(b)(4)) containing 10 test strips.On inspection the test strips and vial showed no defects.The returned test strips were measured with the returned meter in comparison with relevant retention test strips (lot 205400-10) and the current master lot coaguchek xs pt test strip (lot 230734-80).The returned customer material and retention material perform as specified.The complaint was not verified.

• 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: 5333154
• MDR Text Key: 34647589
• Report Number: 1823260-2015-06146
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/12/2016

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: Other Health Care Professional
• Device Catalogue Number: ASKU
• Device Lot Number: 20540013
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/14/2015
• Initial Date FDA Received: 12/29/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/12/2016
• 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