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

Model Number 100139

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Incorrect Or Inadequate Test Results (2456); Low Test Results (2458)

Patient Problems Coagulation Disorder (1779); Death (1802); High Blood Pressure/ Hypertension (1908); Hypovolemic Shock (1917)

Event Date 09/08/2014

Event Type  Death  

Event Description

Caller reported that on (b)(6) 2014, the patient's inratio inr was 3.6 and the laboratory inr was >10.0.The time between testing was ten (10) minutes.The patient's therapeutic range was 2.0 - 3.0.It is unknown if any treatment or medication change was performed at that time.On (b)(6) 2014, the patient was hospitalized for hypertension.The laboratory inr was >15.1.The caller could not provide any information regarding hospitalization or treatment.On (b)(6) 2014, customer was contacted regarding additional information on the patient's hospital stay and outcome.Customer reported that the patient expired on (b)(6) 2014 related to hypovolemic shock.Though requested, the customer would not provide any additional information regarding event due to their interpretation of the hipaa regulation.Multiple attempts were made to obtain additional information with no success.On 10/02/2014, email received from customer reporting that the facilities medical director reviewed the chart and the "pt/inr readings were unrelated to the death of the patient." no additional information provided.

Manufacturer Narrative

Investigation pending.

Manufacturer Narrative

Investigation / conclusion: the products were returned for investigation.The complaint was not confirmed.Investigation of the returned monitor using return strips did not uncover any deficiencies.The monitor continues to meet specification.Retain strip testing on the returned monitor met both accuracy and repeatability criteria.A review of the batch record for the lot did not uncover any non-conformances.Root cause could not be determined from the information provided by the customer.Based on the information available, there is no indication of a product deficiency.No corrective action is required at this time.

Manufacturer Narrative

Corrections: outcome attributed to adverse event: death box checked.Type of reportable event: changed from serious injury to death.Investigation/conclusion: (update): the monitor and unused testing strips were returned for investigation.The complaint was not confirmed.Investigation of the returned monitor using return strips did not uncover any deficiencies.The monitor continues to meet specification.Testing of the returned strips on the returned monitor met both accuracy and repeatability criteria.A review of the batch record for the lot did not uncover any non-conformances.The curve associated with the patient's discrepant inr result was not present in the last 4 curves that were pulled from the monitor memory.Due to this, the impedance curve associated with the discrepant result could not be analyzed for characteristics of a weak-slope change.An impedance curve with a weak-slope change has been identified in (b)(4) as a contributing factor to a potential discrepant result.The root cause could not be determined from the information provided by the customer.Based on the information available, there is no indication of a product deficiency in this case; however, further investigation of discrepant low results associated with the inratio product is documented in (b)(4).

Event Description

An initial mdr was filed for this event based on the reported discrepant result and the hospitalization.Although the hospitalization was due to hypertension and not directly attributable to the patient's coagulation status, alere san diego (asd) conservatively filed this initial mdr as a "serious injury".Following reassessment of these events, asd is conservatively reclassifying and refiling this mdr with "death" as the type of reportable event because the alleged inratio discrepant result cannot be ruled out as potentially contributing to the patient death associated with hypovolemic shock in these circumstances.Although the medical director at the facility where the patient was treated was unequivocal in his opinion that pt/inr readings "were unrelated" to the patient's death, he did not provide any details that enable asd to evaluate the basis for his opinion.In the absence of this specific information, we are conservatively reclassifying and resubmitting this previously reported mdr as a "death" event.

• Brand Name: INRATIO PT/INR TEST STRIPS
• Type of Device: PROTHROMBIN TIME TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; san diego CA
• Manufacturer Contact: ya-ling king ; 9975 summers ridge rd; san diego, CA 92121 ; 8588052084
• MDR Report Key: 4169469
• MDR Text Key: 20660740
• Report Number: 2027969-2014-00914
• 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: Health Professional
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 09/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100139
• Device Lot Number: 349870
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/17/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/10/2014
• Initial Date FDA Received: 10/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-0880, 0881, 0882-2015
• Patient Sequence Number: 1
• Treatment: COUMADIN; INRATIO MONITOR SN (B)(4); INRATIO MONITOR SN (B)(4); COUMADIN
• Patient Outcome(s): Hospitalization; Death
• Patient Age: 89-90
• Patient Sex: Male