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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 630G INSULIN PUMP MMT-1715K 630G BLACK MG; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. 630G INSULIN PUMP MMT-1715K 630G BLACK MG; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-1715K
Device Problem Priming Problem (4040)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/01/2022
Event Type  malfunction  
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.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.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.
 
Event Description
Information received by medtronic indicated that the insulin pump was having issue during prime process.Customer stated that the insulin was squirting out even after the motor stops during fill tubing.Customer stated excess insulin is dripping out of the insulin pump during fill tubing.No harm requiring medical intervention was reported.Troubleshooting was performed.The customer will discontinue to use the device.
 
Manufacturer Narrative
Retainer ring: black.Customer returned pump for alleged prime/fill anomaly found on (b)(6) 2022.The pump passed the displacement test, rewind test, prime/seating test, basic occlusion test, force sensor test, occlusion test, self test, and p-cap locks properly into the reservoir compartment.No "no delivery" alarms noted during testing.Successfully downloaded history files and traces using thus.No prime/fill anomalies were found in the pump memory.Force sensor zero offset within specification.The following were noted during visual inspection: scratched case, pillowing keypad overlay, cracked keypad overlay.Pump was cut open to perform visual inspection and found no evidence of physical or moisture damage.Prime/fill anomaly was not confirmed during testing.This mdr related to the puerto rico manufacturing site has been assigned a medwatch number from the medtronic minimed northridge site, per variance 5.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 Name
630G INSULIN PUMP MMT-1715K 630G BLACK MG
Type of Device
ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
ceiba norte ind. park #50 road
juncos 00777 -386
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
ceiba norte ind. park #50 road
juncos 00777 -386
Manufacturer Contact
tricha miles
ceiba norte ind. park #50 road
juncos 00777--386
7635140379
MDR Report Key13680485
MDR Text Key296847571
Report Number2032227-2022-121332
Device Sequence Number1
Product Code OZO
UDI-Device Identifier000000763000316631
UDI-Public(01)000000763000316631
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberMMT-1715K
Device Catalogue NumberMMT-1715K
Device Lot NumberHG4QMRP
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/01/2022
Initial Date FDA Received03/07/2022
Supplement Dates Manufacturer Received06/16/2022
Supplement Dates FDA Received06/27/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age55 YR
Patient SexFemale
Patient Weight68 KG
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