MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-06-25 for ABBOTT REALTIME CT/NG AMPLIFICATION REAGENT KIT 8L07-91 manufactured by Abbott Molecular, Inc..
[4422694]
A customer in (b)(6) reported that a sample generated a (b)(6) result when run on the ce marked abbott realtime ct/ng assay (list 02g28-91) and a (b)(6) result when run on other assays. The same sample was retested with the ce marked abbott realtime ct/ng assay (list 02g28-91) and was again called (b)(6). The (b)(6) sample results were not reported outside of the laboratory, therefore, there was no impact to patient management. This complaint did not result in death or serious injury. It is unknown at this time if a malfunction has occurred. If this observation was caused by an abbott product malfunction and that malfunction were to recur, a (b)(6) result in the ct/ng assay would not identify a patient as infected with (b)(6) and may result in withholding necessary therapy or spread of the disease. This may lead to serious injury to the patient if the malfunction were to recur. This mdr is submitted because there is an abbott realtime ct/ng assay commercially available in the u. S. (list 8l07-91) that is similar to the ce marked abbott realtime ct/ng assay (list 02g28-91), and may have the same potential for serious injury to the patient if the malfunction were to recur.
Patient Sequence No: 1, Text Type: D, B5
[12106698]
An elevated complaint investigation will be performed at abbott molecular for mdr 3005248192-2014-00005. An mdr follow-up report will be submitted after the complaint investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
[33760881]
Executive summary of the elevated complaint investigation for mdr 3005248192-2014-00005_follow-up report 1: investigation elements / task items summary: investigation into this complaint included an existing data review, a quality data review, and a complaint history review. The results of the investigation are summarized as follows: existing data review:supporting information review: the abbott realtime ct/ng package insert (51-608203/r1) was reviewed. Use only the orange shaft swab provided in the abbott multi-collect specimen collection kit for collecting male urethral, endocervical, or vaginal specimens and processing on the m2000sp. The swab must remain in the transport tube after specimen collection. Do not place multiple swabs or a combination of swab and urine in the transport tube. (51 608203/r1) warnings and precautions section, page 12. The user is responsible for validating the collection, transportation, and storage of specimens not collected, transported, and stored per this package insert. Performance claims have not been established for specimen collection, transportation, and storage that differs from the instructions provided in this package insert for the use of the abbott multi-collect specimen collection kit. (51608203/r1) specimen collection section, page 20. Optimal performance of this test requires appropriate specimen collection, handling, and storage. (51608203/r1) limitations of the procedure section, page 43. A negative result does not exclude the possibility of infection because results are dependent on appropriate specimen collection and absence of inhibitors. The presence of pcr inhibitors may cause invalid results with this product. (51608203/r1) limitations of the procedure section, page 43. As with any diagnostic test, results from the abbott realtime ct/ng assay should be interpreted in conjunction with other clinical and laboratory findings. (51608203/r1) limitations of the procedure section, page 44. A positive result for the presence of n. Gonorrhoeae nucleic acids in the endocervical specimens does not establish the causative agent for salpingitis or pid. A negative result for the n. Gonorrhoeae nucleic acids in the endocervical specimen does not exclude gonococcal infection as a cause of ascending infection. (51608203/r1) limitations of the procedure section, page 43. The lower limit of detection (lod) of the assay is 320 copies of plasmid dna per 400 ul. The ct/ng assay targets the chlamydia cryptic plasmid (present at approximately 10 copies per chlamydia organism) and the multicopy opacity gene of neisseria gonorrhoeae (repeated approximately 11 times per organism). Thus 320 copies of synthetic target per sample input (400 ul) translates to approximately 30 to 40 organisms. (51608203/r1) specific performance characteristics section, page 45. Customer data review: review of the customer data did not verify the alleged complaint for a discrepant patient result. The runs on 05/27/2014 (result log 249), 05/30/2014 (result log 253), and 06/11/2014 (result log 258) were valid, met all assay specification requirements, and no error codes or flags were displayed for the cutoff controls or negative controls. Patient sample 14136598 (tested in result log 249 position f4 and result log 253 position f6) is a true negative result. The patient sample test (result log 258 position c5) was an off label use and is not part of this investigation. There is no indication that the abbott realtime ct/ng amplification kit (list 02g28 91) lot 450877 is performing outside of established design performance specifications. Quality data review: the device history records (dhr) review for abbott realtime ct/ng amplification kit (list 02g28-91) lot 450877 and its components was performed. The review did not identify any issues which could result in the alleged complaint during the production or the release testing for lot 450877. The capa review for abbott realtime ct/ng amplification kit (list 02g28-91) lot 450877 was performed and did not identify any internal or post-production use issues related to this lot number. Complaint history review: the lot specific complaint history review for abbott realtime ct/ng amplification kit (list 02g28 91) lot 450877 did not identify any additional complaint tickets related to this complaint. Product deficiency decision based on the results of the investigation elements a product deficiency for abbott realtime ct/ng amplification kit (list 02g28 91) lot 450877 was not identified. Therefore, this complaint is dispositioned as unconfirmed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005248192-2014-00005 |
| MDR Report Key | 3895571 |
| Report Source | 07 |
| Date Received | 2014-06-25 |
| Date of Report | 2014-05-30 |
| Date of Event | 2014-05-30 |
| Date Mfgr Received | 2014-07-11 |
| Date Added to Maude | 2014-07-16 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| 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 60018331 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60018 3315 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABBOTT REALTIME CT/NG AMPLIFICATION REAGENT KIT |
| Generic Name | CT/NG IN VITRO POLYMERASE CHAIN REACTION (PCR) ASSAY |
| Product Code | MKZ |
| Date Received | 2014-06-25 |
| Catalog Number | 8L07-91 |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MOLECULAR, INC. |
| Manufacturer Address | 1300 EAST TOUHY AVENUE DES PLAINES IL 60018331 US 60018 3315 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-06-25 |