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

Model Number	98814-65
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	02/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
Customer reported being unable to test due to his adc blood glucose meter turning on with button press but not with insertion of test strips.Customer further reported that on (b)(6) 2019, he experienced nervousness and dry mouth, and went to a clinic to get his blood glucose levels measured because he had no other device.A reading of 51 mg/dl was obtained on the hcp meter, and the customer was given something to eat and drink and was told to rest.No further treatment was required.There was no report of death or permanent impairment associated with this event.
Additional Manufacturer Narrative
No product has been returned.An extended investigation has been performed for the reported complaint and it has been determined that there was no indication that the product did not meet specification.A dhr (device history review) for the precision xtra meter was reviewed and the dhr showed the meter passed all tests prior to release.A dhr for the precision test 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.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 product is returned, the case will be re-opened and a physical investigation will be performed.
Event or Problem Description
Customer reported being unable to test due to his adc blood glucose meter turning on with button press but not with insertion of test strips.Customer further reported that on (b)(6) 2019, he experienced nervousness and dry mouth, and went to a clinic to get his blood glucose levels measured because he had no other device.A reading of 51 mg/dl was obtained on the hcp meter, and the customer was given something to eat and drink and was told to rest.No further treatment was required.There was no report of death or permanent impairment associated with this event.

• Brand Name: PRECISION XTRA
• Common Device Name: BLOOD GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502 7001
• MDR Report Key: 8449760
• Report Number: 2954323-2019-02449
• Device Sequence Number: 344694
• Product Code: NBW
• UDI-Device Identifier: 00093815996941
• UDI-Public: 00093815996941
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K070984
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2019

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/30/2019
• Device Model Number: 98814-65
• Device Lot Number: 4500180017
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/27/2019
• Supplement Date Received by Manufacturer: 08/06/2019
• Initial Report FDA Received Date: 03/25/2019
• Supplement Report FDA Received Date: 08/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Weight: 100