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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SENSOR MMT-7040C1 GUARDIAN4 5PK OUS 1 SENSOR, GLUCOSE, INVASIVE

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MEDTRONIC PUERTO RICO OPERATIONS CO. SENSOR MMT-7040C1 GUARDIAN4 5PK OUS 1 SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number MMT-7040C1
Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Calibration Problem (2890)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/31/2022
Event Type  malfunction  
Event Description
Svn: (b)(4) start date of the sensor: (b)(6) 2022. Start hour of the sensor: 00. Sensor start missing reason: location of sensor insertion: stomach. Date of sensor alert: (b)(6) 2022. Hour of sensor alert: 00. Sensor alert missing reason: (b)(6) 2022 16:26:12 pst ice batch user (batch_ice) phone (b)(6), complaint: (b)(4), complaint status: in process mdt initial contact: (b)(6) taken by: (b)(6) 2022, updated for svn _ linnem2 inquired what led up to the complaint. Customer response: customer called to report a failed sensor, this is the third sensor that has failed on day 6 from the same box, previous 2 sensors reported on por (b)(4) change sensor/sensor updating/sg value not available/calibration not accepted t/s per (b)(4). System model number: 780g. Transmitter model: mmt-7840w1. Customer would like to continue troubleshooting. Is this the 2nd call on the same sensor or has the customer called within the last 30 days regarding similar alerts: no expl possible causes of change sensor. Is customer using the minimed 780g system: yes. Did customer receive sensor updating alert: yes. Expl sensor updating alert and possible causes. Did customer receive calibration not accepted alert: yes. Did change sensor alert result from 2 consecutive calibration not accepted alerts: no. Expl calibration not accepted alert and possible causes. Adv to inspect sensor to determine if it is securely taped to skin or if it has moved. Found: no issues with tapes. Adv to inspect sensor to determine if blood is present at the insertion site. Found: no blood. Customer does not report consecutive sensor alerts with different sensors. Customer is able to run test on transmitter. Assisted in performing test on transmitter. Test passed. Offered to review sensor best practices. Customer declined to review. Customer's outcome pertaining to the complaint: troubleshooting additional notes: today 00:18 calibration not accepted 12:22 calibration not accepted 14:02 sensor updating 14:37 sensor updating 15:12 sensor updating 15:37 change sensor ship: 1 x mmt-7040d1/return: nothing country: united kingdom city: south croydon zip: cr2 0fg input date: 05/31/2022 warranty start: 00/00/0000 warranty end: 00/00/0000 batch - hg64dzm.
 
Manufacturer Narrative
(b)(4). Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned. No conclusion can be drawn at this time. We therefore consider this report complete to the best of our knowledge. Medtronic, inc. (medtronic) is submitting this report to comply with 21 c. F. R. Part 803, the medical device reporting regulation. This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda. Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report. This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employees caused or contributed to the event described in the report. In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned". These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803. Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms. This statement should be included with any information or report disclosed to the public under the freedom of information act.
 
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Brand NameSENSOR MMT-7040C1 GUARDIAN4 5PK OUS 1
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
ceiba norte ind. park #50 road
juncos 00777 -386
00777-3869
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
ceiba norte ind. park #50 road
juncos 00777 -386
00777-3869
Manufacturer Contact
tricha miles
ceiba norte ind. park #50 road
juncos 00777--386
  00777-3869
7635140379
MDR Report Key14692049
MDR Text Key302927023
Report Number2032227-2022-213088
Device Sequence Number1
Product Code MDS
UDI-Device Identifier000020763000413396
UDI-Public(01)000020763000413396(17)230315(10)HG64DZM
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 06/14/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/15/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-7040C1
Device Catalogue NumberMMT-7040C1
Device Lot NumberHG64DZM
Was Device Available for Evaluation? No
Date Manufacturer Received05/31/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/15/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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