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

Model Number 100071

Device Problems Nonstandard Device (1420); Low Test Results (2458)

Patient Problems Bruise/Contusion (1754); Hematoma (1884)

Event Date 12/19/2014

Event Type  Injury  

Event Description

On (b)(6) 2015, a phone call was received from the customer inquiring about calibrating his monitor.The customer alleged discrepant low inratio inr result in comparison to the laboratory inr result.On (b)(6) 2014, the patient's inratio inr was 2.6, which was in his therapeutic range of 2.0 - 3.0.On (b)(6) 2015, the patient noticed bruising from his lower stomach to his genitalia.He was seen in the emergency room where he was hospitalized with a hematoma.The laboratory inr was 7.6.Treatment included administration of two (2) units of plasma and vitamin k.In addition, the patient was started on lovenox.The patient was discharged, from the hospital, on (b)(6) 2015; however, he was unable to recall the discharge inr value.On (b)(6) 2015, the inratio inr was 1.4.The patient was unable to provide the lot number since he used the last strip earlier in the day.There was no additional information provided.

Manufacturer Narrative

Investigation pending.

Manufacturer Narrative

(b)(4) investigation/conclusion: the monitor associated with the complaint was returned for investigation.Although the customer did not provide the actual lot number used at the time of the discrepant result, the returned monitor showed that customer utilized strip code la7rn which corresponds to strip lot 353137, with primary product number of 10071.This identifies a lot number that the customer had used with the monitor.This lot was used for internal investigation purposes to evaluate the performance of the inratio pt/inr monitoring system.The complaint was not confirmed during in-house investigation.Investigation of the returned monit using retain strips did not uncover any deficiencies.The monitor and strips continue to meet specification and no product deficiencies were observed.The manufacturing records for the lot were reviewed.The lot met specifications and no relevant non-conformances were documented.An impedance curve analysis was performed to determine if customer's inratio result of 2.6, obtained on (b)(6) 2014, contained a weak slope change.The impedance curve associated with this result appears normal in shape and does not exhibit characteristics of a weak slope change curve.The shape of the curve is consistent with the inratio inr result of 2.6 that was obtained.Internal capa investigation (capa-(b)(4)) has determined that certain patient conditions (e.G.Low hematocrit, elevated plasma proteins) can contribute to discrepant inr results.The customer reported bruising from his lower stomach to his genitalia.The root cause could not be determined from the information provided by the customer.Further investigation will be pursued under capa-(b)(4).

• 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: 4475255
• MDR Text Key: 5400844
• Report Number: 2027969-2015-00071
• 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
• Reporter Occupation: Patient
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 01/10/2015

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: Other
• Device Model Number: 100071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/11/2015
• Initial Date FDA Received: 02/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/11/2015
• 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: LOVENOX STARTED (B)(4); INRATIO MONITOR SN (B)(4); WARFARIN 4MG DAILY
• Patient Outcome(s): Hospitalization; Required Intervention