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

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

Event Description

The customer received questionable results from coaguchek xs meter serial number (b)(4).The result at 7:15 am was 5.8 inr and the result at 7:18 am was 2.8 inr.There was no adverse event.The customer was not anemic, had no heparin therapy, had no changes in dosage, no new medication, no diet changes, no additional illness, and no bleeding or bruising.The therapeutic range was 2.0 inr-3.0 inr.The suspect meter and strips were requested to be returned for investigation.Replacement product was sent.The returned meter and two vials of test 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: vial#(b)(4) 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.Testing results: vial#(b)(4) 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/ 2.5 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 223855-23) 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: 6987173
• MDR Text Key: 91440504
• Report Number: 1823260-2017-02456
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 04625374160
• Device Lot Number: 22385523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/12/2017
• Initial Date FDA Received: 10/30/2017
• 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: 72 YR
• Patient Weight: 91