MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-02-28 for COAGUCHEK ? XS SYSTEM 04625374160 manufactured by Roche Diagnostics.
[137431609]
Occupation is lay user/patient.
Patient Sequence No: 1, Text Type: N, H10
[137431610]
The customer complained of discrepant inr results with coaguchek xs meter serial number (b)(4) compared to an unknown laboratory method. The customer initially received results of 5. 7 inr and 5. 8 inr. Since these results were above the customer's therapeutic range a laboratory test was performed. The result from the laboratory within 7 hours was 3. 9 inr. The customer also re-tested on the meter within 7 hours with a result of 7. 8 inr. The customer may have squeezed finger excessively at the time of the meter tests but wasn't sure. A new finger was used for each meter test. The result from the laboratory was believed to be correct. The customer's warfarin was stopped for 1 night based on the laboratory result. No medical treatment was required. The customer's therapeutic range is 2. 5 - 3. 5 inr. There was no allegation that an adverse event occurred. The customer is fine. The customer has not cleaned the heater plate of the device. The customer is not anemic, does not have anti-phospholipid antibodies and is not on heparin or other direct thrombin inhibitors. The customer has not had any medication changes, diet changes or recent illness. The customer is not experiencing any bleeding or bruising. The meter and test strips were requested for investigation. The meter and test strips were returned. The returned test strips were measured with the returned meter with liquid qc of a high level: qc 1: 2. 2 inr, qc 2: 2. 3 inr, qc 3: 2. 3 inr. The obtained qc values were in the allowed range of the used combination strip lot - qc lot. (1. 7 - 2. 5 inr). All measurements were without error messages. The result of 7. 8 inr alleged by the customer was not observed in the memory of the meter but the alleged results of 5. 7 inr and 5. 8 inr were observed. The customer believes he may have squeezed his finger excessively; excessive squeezing of the finger can cause intracellular fluid to dilute the sample. Relevant retention test strips (lot 368871) were tested in comparison with the master lot coaguchek xs pt. For this purpose, two human blood samples from marcumar donors and two internal reference meters were used. Retention samples were acceptable. No error messages occurred. The investigation did not identify a product problem. The cause of the event could not be determined.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2019-00799 |
| MDR Report Key | 8378006 |
| Report Source | CONSUMER |
| Date Received | 2019-02-28 |
| Date of Report | 2019-04-24 |
| Date of Event | 2019-01-18 |
| Date Mfgr Received | 2019-02-11 |
| Date Added to Maude | 2019-02-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NA MICHAEL LESLIE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214343 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COAGUCHEK ? XS SYSTEM |
| Generic Name | PROTHROMBIN TIME TEST STRIPS |
| Product Code | GJS |
| Date Received | 2019-02-28 |
| Returned To Mfg | 2019-02-21 |
| Model Number | NA |
| Catalog Number | 04625374160 |
| Lot Number | 36887121 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-28 |