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

Catalog Number 07762798016

Device Problem No Apparent Adverse Event (3189)

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

Event Date 01/12/2022

Event Type  malfunction  

Manufacturer Narrative

The test strips were requested for investigation and have not been received at this time.If the product is returned in the future, a follow-up report will be submitted.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.Per product labeling: "coaguchek method uses human recombinant thromboplastin.Therefore, the comparability to tests using other human recombinant thromboplastins is best, whereas higher deviations can occur with other thromboplastin types.However, those higher differences between thromboplastins of different (rabbit, bovine) origin are not an issue specific for coaguchek assays.Similar differences can be observed when a human recombinant thromboplastin-based laboratory method is compared with several other (rabbit, bovine) laboratory methods." occupation is patient/consumer.

Event Description

We received an allegation of a questionable % quick result for one patient tested with the coaguchek inrange meter with serial number (b)(4) compared to an unknown laboratory method.The result from the meter was 64% quick.The result from the laboratory was 50% quick.The time interval between the two tests was within 1 hour.The therapeutic range is 2.2 to 2.8 inr and the middle range is 2.5 inr.Testing is performed once a week.

• 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: 13457299
• MDR Text Key: 287803845
• Report Number: 1823260-2022-00307
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K170960
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: 07762798016
• Device Lot Number: 56561113
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/12/2022
• 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: BLOOD PRESSURE MEDS (2 DIFFERENT) - EVERY 2 DAYS; FALITHROM; FOLIC ACID; LUNDENEROSOL - 2X/DAY
• Patient Age: 68 YR
• Patient Sex: Male