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

Catalog Number 04625374160

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem Coagulation Disorder (1779)

Event Date 10/31/2015

Event Type  Injury  

Manufacturer Narrative

Na.

Event Description

The customer was using coaguchek xs (serial number (b)(4)).He had been testing on the meter (b)(6) 2015 and getting "error 7".The manual states; "if you see `error 7' this means the meter was unable to detect a clot.Repeat the test and call your doctor immediately to arrange for testing using another method." the customer did call his doctor who advised him to hold his warfarin for 2 days and retest on meter.His warfarin was held from (b)(6) 2015.The customer obtained another error 7 on (b)(6) 2015.No information was provided as to whether he called his doctor on (b)(6) 2015.He was taken to the hospital around midnight for symptoms of difficulty breathing, and lazy and dizzy.His son described these as symptoms of high inr for the customer.At the hospital a venipuncture was performed and the lab result at the time of the hospital admission was 23 inr.The customer remained in hospital until (b)(6) 2015 and was treated for his high inr and an infection.No further details were provided regarding the infection.The customer "received vitamin k injection and was transfused at least 2 units of blood".It was stated that the customer's blood counts were low on hospital admission but no further details were given.It is stated that there was no special or unusual diet for the customer.The customer's hematocrit is unknown.He was not on heparin or any direct thrombin inhibitors and he does not have any phospholipid antibodies.The last successful test on the meter prior to the event was (b)(6) and the result was 2.3 inr.There was not another attempt to test until (b)(6).The suspect product was requested to be returned; however, there are no strips left in the vial to return.It was requested that the vial still be returned.

Manufacturer Narrative

The customer returned one vial of test strip lot 200784 ((b)(4)) containing 0 test strips.The vial and stopper showed no noticeable defects.The investigation was unable to test any returned strips as the vial was received without strips.The relevant retention test strips (lot 20078422) were tested in comparison with the current master lot coaguchek xs pt test strip (lot 230734).The retention samples tested acceptably.The retention material performed as specified.

• 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: 5245637
• MDR Text Key: 31994160
• Report Number: 1823260-2015-04621
• 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,other
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 01/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2016
• Device Catalogue Number: 04625374160
• Device Lot Number: 20078422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/09/2015
• 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
• Treatment: ASPIRIN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 072 YR
• Patient Weight: 91