MAUDE Adverse Event Report: BIOSITE INCORPORATED INRATIO2 PT MONITORING SYSTEM; PROTHROMBIN TIME TEST

Model Number 200432

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

Patient Problems Coagulation Disorder (1779); Hemorrhage/Bleeding (1888); Loss of consciousness (2418); Test Result (2695)

Event Date 09/05/2014

Event Type  Injury  

Event Description

Caller alleged discrepant low inratio inr result in comparison to the laboratory inr result.On (b)(6)2014, the customer reported an inratio inr result of 4.6.Pt said she had passed out at home, found by neighbor and woke up in the hospital.Laboratory inr on (b)(6)2014 was 15.Hospitalized fro gastric bleed.Hemoglobin was 7.0 and hematocrit was 21.She was administered four (4) unites of blood initially and transferred to another hospital for more intensive care.Upon arrival, at the higher care facility, the pt's hemoglobin was 8.0 and hematocrit was 28.The pt was administered an additional two (2) units of blood.Pt was discharged on (b)(6) 2014.Though requested, there was no additional info provided.

Manufacturer Narrative

Investigation pending.

Manufacturer Narrative

Investigation / conclusion: the products associated with the complaint were returned for investigation.The complaint was not confirmed during in-house investigation.Investigation of the returned monitor using 10 (ten) retain strips and 2 (two) return 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 non-conformances were documented.No further investigation will be pursued at this time.Based on the information available, there is no indication of a product deficiency.No corrective action is required at this time.

Manufacturer Narrative

Brand name: removed inratio pt/inr test strips (as the complaint device) and added the inratio2 pt monitoring system (monitor) model #: removed inratio pt/inr test strip and added the monitor model 200432 lot#: removed inratio pt/inr test strip lot number and included serial number of monitor as above.Removed the monitor as a concomitant medical product and add the inratio pt/inr test strips.510k#: removed the inratio pt/inr test strip 510k# k092987 and added k072727 to reflect the inratio2 pt monitoring system.(b)(4).Investigation/conclusion: the products associated with the complaint were returned for investigation.The complaint of a discrepant low result was not replicated when the returned monitor and strips were tested using in-house donors.The manufacturing records for the lot were reviewed.The lot met specifications and no non-conformances were documented.This lot met release specifications.Impedance curve analysis was performed on the reported results of 4.0 from 08/29/2014, 4.8 from 09/02/2014, and 4.6 from 09/05/2014.The impedance curve analysis associated with this case exhibited a weak slope change.Our capa investigation capa(b)(4) has determined that impedance curves with weak slope change can cause discrepant results.The capa investigation has also determined that certain patient conditions (e.G.Low hematocrit, elevated plasma proteins) can contribute to weak slope change impedance curves.The patient had kidney disease and a hematocrit of 21% and 28% on (b)(6) 2014.Capa (b)(4) has identified kidney disease and a low hematocrit as conditions that may contribute to a discrepant inr result.A notification letter has been sent to customers to inform them of these patient conditions.A possible root cause is the patient conditions of kidney disease and a low hematocrit of 21% and 28%, which may have contributed to an impedance curve that exhibited a weak-slope change.The inratio meter software may generate an incorrect or discrepant inr result when the patient sample exhibits a weak-slope change impedance curve.Further investigation into these issues will be pursued under capa(b)(4).

• Brand Name: INRATIO2 PT MONITORING SYSTEM
• Type of Device: PROTHROMBIN TIME TEST
• Manufacturer (Section D): BIOSITE INCORPORATED; san diego CA
• Manufacturer Contact: ya-ling king ; 9975 summers ridge rd; san diego, CA 92121 ; 8588052084
• MDR Report Key: 4199279
• MDR Text Key: 5147912
• Report Number: 2027969-2014-00950
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072727
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Distributor
• Reporter Occupation: Not Applicable
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 09/25/2014

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: Lay User/Patient
• Device Model Number: 200432
• Device Lot Number: 348948
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/30/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/25/2014
• Initial Date FDA Received: 10/20/2014
• 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: ASPIRING 80MG DAILY; BACTRIM 1 TABLET MON, WED, FRI; DEPENDING ON INR.; ERYTHROPOIETIN (EPO); HECTORAL 1 MC 3 TIMES A WEEK ; HEPARIN FLUSH WITH DIALYSIS; INRATIO MONITOR SN (B)(4); INRATIO PT/INR TEST STRIPS 100071 LOT #348948; IRON SUPPLEMENTS WHEN NEEDED; NEPHROCAP 1 DAILY; PREDNISONE 5MG DAILY; PROGRAF 2MG TWICE DAILY; PROTEIN SUPPLEMENT; RENVELA 80MG 3 TIMES DAILY; TEMAZEPAM 30 MG; VITAMIN D 1000MG; WARFARIN DOSAGE VARIES BETWEEN 2-6 MG, ; RENVELA 80MG 3 TIMES DAILY; ASPIRING 80MG DAILY; NEPHROCAP 1 DAILY; PROTEIN SUPPLEMENT; HEPARIN FLUSH WITH DIALYSIS; BACTRIM 1 TABLET MON, WED, FRI; WARFARIN DOSAGE VARIES BETWEEN 2-6 MG,; VITAMIN D 1000MG; TEMAZEPAM 30 MG; PREDNISONE 5MG DAILY; PROGRAF 2MG TWICE DAILY; INRATIO MONITOR SN (B)(4); ERYTHROPOIETIN (EPO); HECTORAL 1 MC 3 TIMES A WEEK; IRON SUPPLEMENTS WHEN NEEDED; DEPENDING ON INR.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female