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

Catalog Number 04625374160

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Unexpected Therapeutic Results (1631)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2021

Event Type  malfunction  

Event Description

There was an allegation of questionable results in seconds, instead of inr from coaguchek xs meter up01473372.During troubleshooting, it was discovered the patient's meter was set to the wrong unit of measure and the time/date was also incorrectly set.The unit of measure and time/date on the meter were correctly set on the meter during troubleshooting.The patient did not report the results that were in the wrong unit of measure nor was medication adapted to it.Test strips lot: 52818122 with an expiration date of 31-jul-2022 were used for the following results obtained on (b(6) 2021.The meter result was 6.7 inr at 10:22 am.The meter result was 6.4 inr at 10:20 am.The meter result was 6.7 inr at 11:30 pm.The meter result was 4.6 inr at 11:28 pm.The meter result was 5.7 inr at 11:26 pm.On (b)(6) 2021, the meter result was 4.6 inr at 10:04 am and 2.6 inr at 10:06 am.The meter results obtained on (b)(6) 2021 were taken using test strips lot: 54146321 with an expiration date of 31-dec-2022.The patient's therapeutic range is 2.0-4.0 inr.

Manufacturer Narrative

The meter is provided to u.S.Customers pre-set to the measuring unit inr.There are two additional measuring units on the meter: %quick (%q) and seconds (sec).In the u.S., the most accepted unit of measure is inr.Roche has communicated to all impacted customers instructions on how to confirm results are displayed in the measuring unit inr and the steps to take to change the measuring units back to inr if the meter is displaying the units sec or %q.The test strips were provided for investigation where they were tested using a retention meter and retention controls.Testing results (qc range = 4.1 - 6.8 inr): qc 1: 5.6 inr qc 2: 5.7 inr qc 3: 5.5 inr the obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.On a regular basis, coaguchek strips of lots currently valid in the market are tested as part of routine retention testing and results have passed the internal inspection.The investigation did not identify a product problem.The cause of the event could not be determined.Initial reporter occupation: occupation is patient/consumer.

Manufacturer Narrative

After the initial investigation, the customer's meter and an additional test strip from a second lot (lot: 54146321 expiration date: (b)(6)-2022) were provided for investigation where they were tested using retention controls.Test strip lot #54146321 testing results (qc range = 4.1 - 6.8 inr): qc 1: 5.4 inr the obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.The results alleged by the customer were observed in the meter¿s patient result memory.The returned and the retention material meet the specification.

• 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: 13078347
• MDR Text Key: 288779064
• Report Number: 1823260-2021-03869
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 00365702127104
• UDI-Public: 00365702127104
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 01/21/2022

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: 07/31/2022
• Device Catalogue Number: 04625374160
• Device Lot Number: 52818122, 54146321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/03/2021
• Initial Date FDA Received: 12/23/2021
• Supplement Dates Manufacturer Received: 01/05/2022
• Supplement Dates FDA Received: 01/21/2022
• 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
• Removal/Correction Number: RES 86951
• Patient Sequence Number: 1
• Treatment: WARFARIN
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 114 KG