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

Catalog Number 04625315160

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

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

Event Date 12/05/2022

Event Type  malfunction  

Manufacturer Narrative

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 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.The investigation did not identify a product problem.The cause of the event could not be determined.

Event Description

We received an allegation of questionable inr result with coaguchek xs pro meter serial numbers (b)(6) compared to an unknown laboratory reagent.Sample 1 the meter results were (b)(6)- 2.0 inr/23.9 sec, (b)(6)- 2.1 inr/25.2 sec, (b)(6)- 2.1 inr/24.8 sec the result from the laboratory was >16.0 inr/>120.0 sec.Sample 2 the meter results were (b)(6)- 37.9 sec, (b)(6)- 37.6 sec, (b)(6)- 37.8 sec.The result from the laboratory was 28.6 sec.Sample 3 the meter results were (b)(6)- 3.7 inr/44.7 sec, (b)(6)- 3.7 inr/44.0 sec, (b)(6)- 3.7 inr/44.7 sec.The result from the laboratory was 2.7 inr/28.9 sec.Sample 4 the meter results were (b)(6)- 34.4 sec, (b)(6)- 34.7 sec, (b)(6)- 34.4 sec.The result from the laboratory was 25.5 sec.Sample 5 the meter results were (b)(6)- 4.7 inr/56.5 sec, (b)(6)- 4.6 inr/55.4 sec, (b)(6)- 4.6 inr/55.4 sec.The result from the laboratory was 3.0 inr/31.4 sec.Sample 6 the meter results were (b)(6)- 3.5 inr, (b)(6)- 3.4 inr, (b)(6)- 3.4 inr.The result from the laboratory was 2.6 inr.Sample 7 the meter results were (b)(6)- 1.9 inr/22.5 sec, (b)(6)- 1.9 inr/22.3 sec, (b)(6)- 1.9 inr/22.6 sec.The result from the laboratory was 1.6 inr/19.4 sec.Sample 8 the meter results were (b)(6)- 49.4 sec, (b)(6)- 49.4 sec, (b)(6)- 49.2 sec.The result from the laboratory was 34.6 sec.Sample 9 the meter results were (b)(6)- 3.7 inr/44.5 sec,, (b)(6)- 3.7 inr/44.2 sec, (b)(6)- 3.7 inr/44.3sec.The result from the laboratory was 2.8 inr/29.5 sec.Sample 10 the meter results were (b)(6)- 3.5 inr/41.6 sec, (b)(6)- 3.5 inr/41.7 sec, (b)(6)- 3.5 inr/41.5 sec.The result from the laboratory was 2.8 inr/29.8 sec.Sample 11 the meter results were (b)(6)- 3.0 inr/36.4 sec, (b)(6)- 3.1 inr/36.9 sec (b)(6)- 3.1 inr/36.7 sec.The result from the laboratory was 2.78 inr/29.7 sec.Sample 12 the meter results were (b)(6)- 34.7 sec, (b)(6)- 34.8 sec, (b)(6)- 34.9 sec.The result from the laboratory was 26.2 sec.Sample 13 the meter results were (b)(6)- 3.2 inr/38.0 sec, (b)(6)- 3.1 inr/37.7 sec, (b)(6)- 3.2 inr/38.4 sec.The result from the laboratory was 2.6 inr/28.2 sec.Sample 14 the meter results were (b)(6)- 41.3 sec, (b)(6)- 42.0 sec, (b)(6)- 42.1 sec.The result from the laboratory was 32.0 sec.Sample 15 the meter results were (b)(6)- 35.4 sec, (b)(6)- 35.2 sec, (b)(6)- 34.8 sec.The result from the laboratory was 22.8 sec.No therapeutic ranges were provided.

• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 17986937
• MDR Text Key: 327322857
• Report Number: 1823260-2023-03393
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 00365702128101
• UDI-Public: 00365702128101
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04625315160
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1