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

Catalog Number 04625374160

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Thromboembolism (2654); Insufficient Information (4580)

Event Date 02/28/2022

Event Type  malfunction  

Event Description

There was an allegation of questionable results from coaguchek xs meter serial number (b)(4) compared to a laboratory using an unknown reagent.The following comparison was provided.On "28/2/2" the meter result was allegedly 1.3 inr.This result was present in the meter memory on (b)(6) 2002.The laboratory result was reportedly 3.5 inr.As the date and time on the meter were set incorrectly, the actual date and time of these results was unknown.On (b)(6) 2022, at an unknown time, it was alleged that the meter result was 1.8 inr.At an unknown time, the laboratory result using an unknown reagent was reportedly 3.8 inr.On (b)(6) 2022 at 5:00 am, it was alleged that the meter result was 6.6 inr.At 7:30 am, the laboratory result using an unknown reagent was reportedly 3.3 inr.The therapeutic range was 3.0-3.5 inr and the patient tests weekly.

Manufacturer Narrative

The returned vial of strip lot 54146321 was empty.The meter was provided for investigation where it were tested using retention strips and retention controls.Testing results (qc range = 4.1 - 6.8 inr): qc 1: 5.1 inr.Qc 2: 5.2 inr.Qc 3: 5.2 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 reporter were not observed in the meter¿s patient result memory.On a regular basis, coaguchek strips of lots currently valid in the market are tested as part of routine retention testing and the results have passed the internal inspection.Per product labeling, "coaguchek uses human recombinant thromboplastin.Therefore, the comparability to other human recombinant thromboplastins is best, whereas higher deviations can occur with other thromboplastins.However, those higher differences between thromboplastins of different (rabbit, bovine based) origin are not a coaguchek specific issue.Similar differences can be observed when a human recombinant thromboplastin-based laboratory method is compared against several other (rabbit, bovine-based) laboratory methods." occupation was patient/consumer (patient's caregiver).

• 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: 14322420
• MDR Text Key: 299161595
• Report Number: 1823260-2022-01306
• 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
• Report Date: 05/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 04625374160
• Device Lot Number: 54146321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2022
• Date Manufacturer Received: 04/08/2022
• 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
• Patient Sequence Number: 1
• Treatment: ASPIRIN; CITALOPRAM; DOCUSATE; EMPAGLIFLOZIN; METOPROLOL; NORTRIPTYLINE; SACUBITRIL; SPIRONOLACTONE; WARFARIN
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 93 KG