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 10/12/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer received questionable results from coaguchek xs meter serial number (b)(4).The customer had dropped the meter and the batteries had come out.He stated he was getting results like 8, 9, and 12 and the meter was displaying a date of (b)(6).Customer support advised the customer how to set the meter date and time and assisted with changing the units to inr as the units were set to %q.The obtained results were reviewed in the meter memory on a date of (b)(6).At 11:05 am, the result was 5.5inr (9%q).At 11:07 am, the result was 4.1inr (12%q).At 11:15 am, the result was 5.5inr (8%q).It was determined the date and time were not set correctly at the time of the customer's testing.He confirmed the testing was actually performed on (b)(6) at 3:15 am and all the results were performed back to back.The customer did not stick a new finger for each testing.He stuck the same finger for all three tests.The customer stated he was on an antibiotic and just got back from cruise ship trip where he ate new foods.The customer was also taking 12 other medications, but declined to provide any information about them.The therapeutic range was 2.0-3.0 inr.There was no adverse event and the customer stated he feels great.The suspect meter and strips were requested to be returned for investigation.Replacement product was sent.The returned meter and strips were tested in comparison to a retention meter and masterlot strips.Two human blood samples from warfarin donors and internal reference meters were used.Donor inr: 2.7 inr and 2.5 inr.Donor hct: 49% and 47%.Testing results: donor #1: master lot / customer strip and meter 2.6 inr/ 2.6 inr.Donor #2: master lot / customer strip and meter 2.4 inr/ 2.4 inr.All results were within the specified maximum difference between measurements.No error messages occurred.The returned and the retention material meet the specification.Relevant retention test strips (lot 207426-21) were tested in comparison with the current master lot coaguchek xs pt test strip (lot 124158-80).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 and retention material performed as specified.No information was provided in the complaint case that would point to a cause for the result discrepancy.

• 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: 6987087
• MDR Text Key: 91442019
• Report Number: 1823260-2017-02455
• 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: Patient
• Type of Report: Initial
• Report Date: 10/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 04625374160
• Device Lot Number: 20742621
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/12/2017
• 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
• Patient Age: 65 YR