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

Catalog Number 04625374160

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/10/2018

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi)#: (b)(4).

Event Description

The patient called stating that her coaguchek xs meter serial number (b)(4) was reporting values in % quick units.With help from technical service personnel, the patient was able to program the meter correctly.Upon review of the meter memory, erroneous values were observed.Each value was measured with a different test strip lot number.Patient identifiers for information related to each affected test strip lot number: (b)(6).At 8:42 a.M., a sample from the patient was tested on the meter using test strip lot number 27216321, resulting as 4.8 inr.At 8:46 a.M., a sample from the patient was tested on the meter using test strip lot number 27216421, resulting as 3.0 inr.No adverse events were alleged to have occurred with the patient.The patient did not report the meter results to a doctor, so the patient did not receive treatment or changes in medication.The patient's therapeutic range is 2.0 - 3.0 inr.The patient's testing frequency is once per week.The patient is not anemic or polycythemic.The patient does not have antiphospholipid antibodies.The patient does not take heparin, lovenox, or thrombin inhibitors.The patient has not had changes in diet.The patient did not have a special or unusual diet.The patient does not have bruising or bleeding.The patient's product was requested for investigation and replacement product was sent to the patient.Relevant retention test strips (lot 27216421) were tested in comparison with the current master lot.For this purpose two human blood samples from marcumar donors and two internal reference meters were used.No error messages occurred.Retention samples were within specifications.

Manufacturer Narrative

The patient retuned a meter for investigation.The returned meter was tested in comparison to a retention meter and master lot strips.Human blood samples from warfarin donors were used.Donor 1 inr: 2.3 inr, donor 2 inr: 2.0 inr.Donor 1 hct: 50%, donor 2 hct: 42%.Testing results: donor 1: retention meter with master lot strips: 2.3 inr, customer meter with master lot strips: 2.3 inr.Donor 2: retention meter with master lot strips: 2.0 inr, customer meter with master lot strips: 2.0 inr.All inr values were within the specified maximum difference between measurements.No error messages occurred.The returned and the retention material meet the specifications.Relevant retention test strips (lot 272164) were tested in comparison with the current master lot.For this purpose two human blood samples from marcumar donors and two internal reference meters were used.No error messages occurred.Retention samples were acceptable.

• Brand Name: COAGUCHEK ® XS SYSTEM
• Type of Device: PROTHROMBIN TIME TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7548725
• MDR Text Key: 109908070
• Report Number: 1823260-2018-01626
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 06/04/2018

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: 05/31/2019
• Device Catalogue Number: 04625374160
• Device Lot Number: 27216421
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/10/2018
• Initial Date FDA Received: 05/29/2018
• Supplement Dates Manufacturer Received: 05/10/2018
• Supplement Dates FDA Received: 06/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AMIODARONE; BREATHING MACHINE; COUMADIN; LISINOPRIL; LYRICA; PREDNISONE; TOPROL
• Patient Age: 75 YR
• Patient Weight: 55