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

Model Number 100071

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

Patient Problems Death (1802); Test Result (2695)

Event Date 09/25/2014

Event Type  malfunction  

Event Description

On 01/08/2015, a phone call was received from the patient's daughter inquiring about the medical conditions listed in the alere inratio pt/inr monitor system urgent medical device correction notification, dated december 05, 2014.She reported that her mother expired on (b)(6) 2014 and may have had some of the medical conditions listed.She stated that "she believes her mother may have been given wrong dosages due to inaccurate results and wrong treatment which may have contributed to her mother death".In an attempt to obtain complete information, the distributor, alere home monitoring, inc.(ahm), the cardiology department at the patient's coumadin clinic, the home health care provider and the envision home health (hospice care) medical records department were contacted and the following is a chronological history of available information.(b)(6) 2013: patient started home health care.There was no data recorded in files, until (b)(6) 2014.There were no laboratory inr results on file.(b)(6) 2014: inratio inr=7.4 (warfarin dose withheld); (b)(6) 2014: inratio inr=3.5 (warfarin dose withheld - patient out of town); (b)(6) 2014: warfarin dosing at 3mg daily; (b)(6) 2014: inratio inr=1.5 (warfarin continued at 3mg daily); (b)(6) 2014: inratio inr=1.6 (warfarin dose increased to 4mg on monday and thursday and 3mg rest of the week); (b)(6) 2014: inratio inr=3.4 (warfarin dose decreased to 4mg on monday and 3mg rest of the week); (b)(6) 2014: inratio inr=2.0 (no dosage change); (b)(6) 2014: inratio inr=2.5 (no dosage change).(b)(6) 2014: inratio inr=1.3 (missed doses) patient reported to be non-compliant with the regularity of her medications as she traveled a lot and would not take her medications or perform her testing.(warfarin changed to 6mg x 1 dose and then 4mg on monday and 3mg rest of week).(b)(6) 2014: last home health note: "insulin not administered, patient not taking meds/not eating".(b)(6) 2014: department of human resources of texas performed capacity assessment - patient moderately impaired, recommend placement in facility.Between the month of (b)(6) 2014, the patient changed from cardiologist care to hospice care and diagnosed as terminal to receive optimal care.The following inratio inr results were documented however there was no medication dosing or changes documented.If medication was adjusted, after a result that was obtained outside the patient's therapeutic range, that could explain the discrepancy in the following inr result.(b)(6) 2014: inratio inr=2.9 (considered date of event since medication dosing changes were not available to explain the patient result variability.) (b)(6) 2014: inratio inr=5.3; (b)(6) 2014: inratio inr=2.0; (b)(6) 2014: inratio inr=2.6; (b)(6) 2014: inratio inr=2.9; (b)(6) 2014: inratio inr=3.4; (b)(6) 2014: inratio inr=2.3; (b)(6) 2014: inratio inr=2.4 ; (b)(6) 2014: inratio inr=3.8; (b)(6) 2014: inratio inr=3.0.(b)(6) 2014: the patient expired due to "respiratory failure".The report filing is due to the variability in the patient results starting (b)(6) 2014.There were no laboratory inr results available for comparison.There is no information to suggest that the result variability caused or contributed to the subsequent death, which occurred approximately two (2) months later.Though requested, there was no additional information provided.

Manufacturer Narrative

Investigation/conclusion: a relative of the patient was prompted to report this complaint after receiving the medical device correction letter, which described patient conditions that could contribute to a discrepant low inratio result compared to a reference result.The patient was reported to have a number of medical conditions including chronic obstructive pulmonary disease (copd), congestive heart failure (chf), parkinson's, and dementia.In addition, the patient was reported to be moderately impaired.The cause of death was determined to be respiratory failure.With the historical list of the patient's medical conditions, additional medications may have been administered throughout the use of inratio device.These factors may impact coagulation time.Additionally, the patient has a reported history of being non-compliant on general self-administration of coumadin.The eighteen (18) inratio inr results provided were obtained over a span of approximately four months.The time between each result ranges from two days to 3 weeks.Changes in patient's status, including changes in medication, may have contributed to the high variability observed between results.Since he patient's therapeutic range and corresponding reference values were not provided, the accuracy of the patient's results are unable to be determined.A review of retain strip testing for the reported lot, and a lot of similar genealogy was conducted.The results for these lots met both accuracy and strip repeatability criteria.The product performed as expected and there were no product deficiencies observed.A review of the manufacturer record, for the lots, did not uncover any non-conformance abd both lots met release specification.It is unable to be determined if customer's complaint is related to the issues described in the correction letter, because it is unknown whether the patient's reported inratio inr results were discrepant.Based on the information available, there is no indication of a product deficiency and no corrective action is required at this time.

• Brand Name: INRATIO PT/INR TEST STRIPS
• Type of Device: PROTHROMBIN TIME TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego CA 92121
• Manufacturer (Section G): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego CA 92121
• Manufacturer Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 4483910
• MDR Text Key: 19312897
• Report Number: 2027969-2015-00069
• 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: Other
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 01/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2015
• Device Model Number: 100071
• Device Lot Number: 348355
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/08/2015
• Initial Date FDA Received: 02/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2014
• 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
• Treatment: WARFARIN; UNSPECIFIED ANTIBIOTIC; INSULIN (UNKNOWN IF TAKING ON DATE OF EVENT); INRATIO MONITOR SN (B)(4)
• Patient Age: 79 YR