MAUDE Adverse Event Report: COOPERSURGICAL, INC. LIFEGLOBAL MEDIA; IVF MEDIUM

Model Number SEE H11

Device Problem Chemical Problem (2893)

Patient Problem Insufficient Information (4580)

Event Date 02/26/2024

Event Type  Injury  

Event Description

It was reported by the patient, after being contacted by an operational genetic counselor from coopersurgical, that she underwent ivf treatment and subsequently became pregnant.At 12 weeks, an ultrasound allegedly shows the fetus to be missing a right hand.Fetus appears to be healthy in all other regards.Attempts have been made, but no additional information has been provided.1216677-2024-00013 unk lggg ivf media (b)(4).

Manufacturer Narrative

Product location is unknown.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

D4: model #: lggg-020 or lggg-050 or lggg-100.Lot #: 231020-0187421 or 231020-018742 or 231020-018743.Udi#: (b)(4).H4: 20-oct-2023 or 16-oct-2023 or 31-oct-2023.Distribution history: the lggg-050 was manufactured at csi on 20-oct-2023 and lggg-020 was manufactured at csi on 16-oct-2023 and lggg-100 was manufactured at csi on 31-oct-2023.Manufacturing record review: all the dhrs related to the lggg recall the following dhrs were reviewed: product lggg-020 lot: 231020-018741 and subassemblies (86050020 lot: 231020-018745 and 8605 lot: 231020-018744), lggg-050 lot 231020-018742 (86050050 lot: 231020-018746 and, 8605 lot: 231020-018744) and lggg-100 lot 231020-018743 (86050100 lot: 231020-018747 and 8605 lot: 231020-018744) were reviewed and related ncmr-2023-11-00015 to the problem reported in this complaint.The ncmr was related to a failure of the mea embryonic growth and development test; however, mea eg&d is not a test required as a release requirement.The mea eg&d is a test that sorts the embryos that develop after incubation in the test article and does not evaluate the functionality of the medium like the regular mea test performed on the test article, which passed the test with no problems.For that reason, the product was released using the results of the regular mea test.Product receipt: the complaint product has not been returned to coopersurgical.Visual evaluation: samples from the same lot number were inspected and as result the color appearance were as expected.Functional evaluation: retention samples from the same lot number were tested.The mea test and ph test performed passed; however, the mea eg&d test requested as additional information, failed.Please refer to the results of the qc testing of the retention samples attached to this investigation report.Moreover, samples received from distribution center were tested.Sterility test, ph, osmolality, lal endotoxin, gentamicin and hsa concentration, were performed, and all passed according to specifications.Please refer to the qc test results of the dc samples attached to this investigation report.Samples returned from customer, related to the same complaint lot were tested and failed the mea eg&d test.As part of capa investigation and since the mea eg&d fail, additional chemical tests were performed (potassium phosphate and magnesium sulfate) and the results determined an absent of the magnesium component and double concentration of potassium phosphate.Root cause analisys: based on the complaint details recorded in the report, it was determined through our fpp team that this product and lot was associated to the lggg ivf media recall.To determinate the possible root causes a capa was opened.At the end of the investigation process it was determinate that the potential root causes were: i.Material: containers for storing the raw material (magnesium sulfate and potassium phosphate) are identical in color & shape.2.Method: current process lacks measures to prevent potential confirmation bias mix ups within the weighing steps and addition of raw material during the formulation of the media product.Additionally, as contribute factor is determinate that the testing package was designed with the specific testing according to the product requirements, that was not capable of detecting missing critical components such as magnesium sulfate in the product.The allegations of this complaint could not be confirmed.

Event Description

No additional information is available.

• Brand Name: LIFEGLOBAL MEDIA
• Type of Device: IVF MEDIUM
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull; CT 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611 ; 4752651582
• MDR Report Key: 18935734
• MDR Text Key: 338069564
• Report Number: 1216677-2024-00013
• Device Sequence Number: 1
• Product Code: MQL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/24/2024

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/29/2023
• Device Model Number: SEE H11
• Device Catalogue Number: SEE H11
• Device Lot Number: SEE H11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/19/2024
• Supplement Dates Manufacturer Received: 04/26/2024
• Supplement Dates FDA Received: 05/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Congenital Anomaly
• Patient Sex: Female