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

Model Number	98814-65
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/13/2018
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.The date of event is unknown.The device mfg date is unknown.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
Customer reported her adc blood glucose meter was "giving false readings" and that "because of the readings, (she) been at the hospital last year".Readings of 342 mg/dl and 261 mg/dl were reportedly obtained on the adc meter but it is unknown when these readings were obtained related to the reported hospital visit.No further information was provided by the customer as she declined to continue troubleshooting.There was no report of death or permanent impairment associated with this event.
Additional Manufacturer Narrative
No product has been returned.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.The useful life of precision xceed (xtra) meter is 5 years.As the manufacturing date of this product is before 2010, it has been in distribution beyond its useful life as of the case awareness date of (b)(6) 2018.Since the product exceeded its useful life, it is determined to have met specification when the product was released and through its lifespan.Therefore, no further investigation activities are required for the precision xceed meter.A 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 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.This also serves as a correction report.(initial reporter's) information and (pma510k#) were incorrectly documented in the initial mdr 30 day report.Both sections have been updated.(expiration date) has also been updated per case details.
Event or Problem Description
Customer reported her adc blood glucose meter was "giving false readings" and that "because of the readings, (she) been at the hospital last year".Readings of 342 mg/dl and 261 mg/dl were reportedly obtained on the adc meter but it is unknown when these readings were obtained related to the reported hospital visit.No further information was provided by the customer as she declined to continue troubleshooting.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: 7419646
• Report Number: 2954323-2018-02757
• Device Sequence Number: 1446482
• Product Code: NBW
• UDI-Device Identifier: 00093815996941
• UDI-Public: (01)00093815996941(17)20181231(10)4500169248
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K040814
• 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): 12/26/2018

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: 12/31/2018
• Device Model Number: 98814-65
• Device Catalogue Number: 99694
• Device Lot Number: 4500169248
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/13/2018
• Supplement Date Received by Manufacturer: 11/29/2018
• Initial Report FDA Received Date: 04/10/2018
• Supplement Report FDA Received Date: 12/26/2018
• 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