MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. PRECISION XTRA; BLOOD GLUCOSE MONITORING SYSTEM

Model Number 98814-65

Device Problems Device Displays Incorrect Message (2591); Calibration Problem (2890)

Patient Problem Hyperglycemia (1905)

Event Date 08/02/2018

Event Type  Injury  

Manufacturer Narrative

The customer's products have been requested for investigation.A follow-up report will be filed once the product is returned or additional information is obtained.The date of manufacture is unknown.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A caller, calling on behalf of a customer, reported the customer received multiple error messages from his adc blood glucose meter, and a calibration issue, which prevented a reading from being displayed.Caller further reported that on (b)(6) 2018 customer was showing signs of ¿mental status confusion and weakness¿ so he was taken to a hospital.At the hospital a reading of 500 mg/dl was received.Customer was diagnosed with hyperglycemia and a cerebral vascular accident and treated with an unspecified intravenous infusion and insulin via injection.Customer was hospitalized and discharged on (b)(6) 2018.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

The reported meter has been returned and investigated with retained test strips.Visual inspection has been performed on the reported meter and no issues were observed.Meter powered on with button depression, cal bar, and strip insertion.Meter was calibrated and recalled successfully.The calibration code was not lost or changed.Control solution testing has been performed.All results were within range specification and no errors were observed during control solution testing.The complaint is not confirmed.

Event Description

A caller, calling on behalf of a customer, reported the customer received multiple error messages from his adc blood glucose meter, and a calibration issue, which prevented a reading from being displayed.Caller further reported that on (b)(6) 2018 customer was showing signs of ¿mental status confusion and weakness¿ so he was taken to a hospital.At the hospital a reading of 500 mg/dl was received.Customer was diagnosed with hyperglycemia and a cerebral vascular accident and treated with an unspecified intravenous infusion and insulin via injection.Customer was hospitalized and discharged on (b)(6) 2018.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Since the reported test strips have not been returned, extended investigation has been performed for the reported complaint and determined that there was no indication that the product did not meet specification.Dhr (device history review) for the precision strips was reviewed and the dhr showed the precision strips passed all tests before release.Retain testing was performed for the precision strips and all units performed within specification.The meter was returned and determined to have satisfactory control solution testing results during the physical investigation and no other issues were identified.Therefore, no further investigation activities were performed for the meter.All review activities conducted above, including but not limited to the final release testing specifically associated with the manufacture of this product, are sufficient information in order to show if the product has met specifications prior to release.If the test strips are to be returned, the case will be re-opened and a physical investigation will be performed.

Event Description

A caller, calling on behalf of a customer, reported the customer received multiple error messages from his adc blood glucose meter, and a calibration issue, which prevented a reading from being displayed.Caller further reported that on (b)(6) 2018 customer was showing signs of ¿mental status confusion and weakness¿ so he was taken to a hospital.At the hospital a reading of 500 mg/dl was received.Customer was diagnosed with hyperglycemia and a cerebral vascular accident and treated with an unspecified intravenous infusion and insulin via injection.Customer was hospitalized and discharged on (b)(6) 2018.There was no report of death or permanent injury associated with this event.

• Brand Name: PRECISION XTRA
• Type of Device: BLOOD GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.; 1360 south loop road; alameda CA 94502 7001
• MDR Report Key: 7987374
• MDR Text Key: 124463824
• Report Number: 2954323-2018-07847
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00681131060301
• UDI-Public: 00681131060301
• Combination Product (y/n): N
• PMA/PMN Number: K040814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2019
• Device Model Number: 98814-65
• Device Lot Number: 80487
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2018
• Date Manufacturer Received: 10/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Weight: 103