MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. INRATIO PT/INR TEST STRIPS; PROTHROMBIN TIME TEST

Model Number 100071

Device Problems Incorrect Or Inadequate Test Results (2456); Low Test Results (2458)

Patient Problems Anemia (1706); Coagulation Disorder (1779); Hemorrhage/Bleeding (1888); Inflammation (1932); Test Result (2695)

Event Date 08/10/2015

Event Type  Injury  

Manufacturer Narrative

Investigation pending.

Event Description

Patient self tester called because he was concerned that his technique may have caused him to receive a lower than expected result when testing his inratio.His test result on (b)(6) 2015 was inratio=1.1.While on the phone with technical service rep, the patient self tester ran another inratio test with a result of 1.0.The patient self tester encountered technique issues: added multiple drops of blood; touched his finger to the sample well when applying sample; sample was not applied immediately after the fingerstick.It was also noted that the patient's hematocrit was not in the validated range.On (b)(6) 2015 the patient self tester's inratio inr=3.0.During the call the patient self tester stated that he went to (b)(6) hospital in (b)(6) on (b)(6) 2015 for bleeding from his colon.He was diagnosed with diverticulitis and was anemic.His hemoglobin was 6.0 and he was given 2 pints of plasma and 2 pints of blood; taken off coumadin and put on an iron rich diet.Patient self tester was not able to confirm if his inr was tested in the hospital and he indicated that he did not test inr on his own inratio monitor during his hospital stay; he was not placed on any heparin or lovenox while in the hospital.On (b)(6) 2015 patient self tester's hemoglobin was at 8.1; on (b)(6) his hemoglobin=9.4 (hematocrit roughly equal to 28.2).Patient has been following instructions from his doctor to increase his hemoglobin and believed that it was steadily increasing.A more recent hemoglobin value was not available.

Manufacturer Narrative

No reference values were provided to correspond to the customer's inratio inr results.The accuracy of these results cannot be determined without this information.It is indicated that the product is not returning for evaluation.Therefore, a review of the entire in-house testing history of the lot was performed.In-house testing on strip lot 365429a was found to be performing within expectations.A review of the manufacturing records for the lot did not uncover any non-conformances.The lot meets release specification.Improper techniques were identified in the complaint.This cannot be ruled out as a cause for the unexpected results.It was reported that the customer was diagnosed with diverticulitis.This condition may affect the performance of the assay.The customer also was diagnosed with anemia and had calculated hematocrits below the acceptable range.This also cannot be ruled out as a cause for the unexpected results.

• Brand Name: INRATIO PT/INR TEST STRIPS
• Type of Device: PROTHROMBIN TIME TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge rd.; san diego CA 92121
• Manufacturer (Section G): ALERE SAN DIEGO, INC.; 9975 summers ridge rd.; san diego CA 92121
• Manufacturer Contact: ya-ling king ; 9975 summers ridge rd.; san diego, CA 92121 ; 8588052084
• MDR Report Key: 5055205
• MDR Text Key: 24995014
• Report Number: 2027969-2015-00649
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor
• Reporter Occupation: Patient
• Type of Report: Followup
• Report Date: 08/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 100071
• Device Lot Number: 365429A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention