MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-14 for ANEUVYSION MULTICOLOR DNA PROBE KIT 05J38-50 manufactured by Abbott Molecular, Inc..
[22385941]
Abbott molecular has contacted the customer and requested more information regarding this event. It is unknown at this time if an abortion occurred. An mdr follow-up report will be submitted to fda after a customer response is received.
Patient Sequence No: 1, Text Type: N, H10
[22385942]
The aneuvysion (vysis cep 18, x, y-alpha satellite, lsi 13 and 21) multicolor probe panel is intended to use cep 18/x/y probe to detect alpha satellite sequences in the centromere regions of chromosomes 18, x, and y, and lsi 13/21 probe to detect the 13q14 region and the 21q22. 13 to 21q22. 2 region. The aneuvysion kit is indicated for identifying and enumerating chromosomes 13, 18, 21, x, and y via fluorescence in situ hybridization (fish) in metaphase cells and interphase nuclei obtained from amniotic fl uid in subjects with presumed high risk pregnancies. It is not intended to be used as a stand alone assay for making clinical decisions. Fish results are intended to be used as an aid in the diagnosis of numerical abnormalities of chromosomes 13, 18, 21, x and/or y in conjunction with other information currently used in prenatal diagnosis, consistent with professional standards of practice [1]. This device is intended for use only with amniocyte cells; it is not intended for and has not been validated for use with other test matrices. This fish assay will not detect the presence of structural chromosome abnormalities that can also result in birth defects. This fish assay will be performed in cytogenetics laboratories. A customer in (b)(6) reported a discordant result between an aneuvysion test result of xo and a karyotype analysis result of xx. Because it is not known whether an abortion was performed or not, the event is being reported because of the potential risk of death or serious injury.
Patient Sequence No: 1, Text Type: D, B5
[24683509]
Summary of elevated complaint investigation (ecinv) (b)(4) results for mdr 3005248192-2015-00014 follow-up report 1: investigation into this complaint included testing of the abbott molecular (am) retention samples from the aneuvysion lot of material in question, an evaluation of the quality data review (device history record (dhr) review and capa review) and complaint history review. Quality data review: device history record / batch record review: verified that product met specifications at the time of release. Capa / non-conformance review: no related capas were identified. Product/system/instrument evaluation: retain / file sample evaluation: the retention sample passed quality specifications. Performance parameters include intensity, background, specificity and cross-hybridization. No evidence of a performance issue was identified. Return sample evaluation: the customer's sample was not available for investigation. Complaint history review: no additional related complaints were identified. Product deficiency decision based on the results of the investigation elements, a product deficiency for the aneuvysion multicolor dna probe kit, 50 assay-ivd: part# 35-161075 has not been identified. Clarification: per the e-submitter instructions displayed in section a/ patient information, the first day of the month is to be used when the day is unknown for all date fields in this 3500a form. Based on this instruction, a date of (b)(6) 2015 was entered as the event onset date because the exact day that the pregnancy was terminated in unknown. The pregnancy was terminated between (b)(6) 2015. Patient information, the patient birth date and the patient weight fields are blank because this information is unknown.
Patient Sequence No: 1, Text Type: N, H10
[24683510]
Updated information: the date the aneuvysion test was reported was (b)(6) 2015. The patient did undergo an abortion in (b)(6) 2015, before the karyotype result was available on (b)(6) 2015. The day in (b)(6) 2015 that the pregnancy was terminated is unknown. The gestational age was (b)(6). It is unknown why an abortion was recommended prior to receipt of the karyotype results. It is unknown whether the kayotype result would have changed the treatment recommendation. In this case no additional result was used in combination with the fish result to make the clinical decision to recommend an abortion. After the initial aneuvysion result of xo, the test was repeated and again resulted in xo. There was increased risk for fetal trisomy identified by maternal serum screening. No family history indicated. The ultrasound results indicated appearance of bilateral choroid plexus cysts. No other clinical indications/ risk factors were indicated. The fish analysis result indicated more than 82% signal showed the chromosomal karyotype was 45, xo. The cell culture result indicated the chromosomal karyotype was 46, xx.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005248192-2015-00014 |
| MDR Report Key | 4914156 |
| Date Received | 2015-07-14 |
| Date of Report | 2015-07-07 |
| Date of Event | 2015-06-01 |
| Date Mfgr Received | 2015-07-15 |
| Date Added to Maude | 2015-07-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JEAN LEETE |
| Manufacturer Street | 1300 EAST TOUHY AVENUE |
| Manufacturer City | DES PLAINES IL 600183315 |
| Manufacturer Country | US |
| Manufacturer Postal | 600183315 |
| Manufacturer Phone | 2243617274 |
| Manufacturer G1 | ABBOTT MOLECULAR, INC. |
| Manufacturer Street | 1300 EAST TOUHY AVENUE |
| Manufacturer City | DES PLAINES IL 600183315 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 600183315 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANEUVYSION MULTICOLOR DNA PROBE KIT |
| Generic Name | DNA-PROBE, HUMAN CHROMOSOME, PRODUCT CODE: MAO |
| Product Code | OYU |
| Date Received | 2015-07-14 |
| Catalog Number | 05J38-50 |
| Lot Number | 457601 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MOLECULAR, INC. |
| Manufacturer Address | 1300 EAST TOUHY AVENUE DES PLAINES IL 600183315 US 600183315 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-07-14 |