MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional, report with the FDA on 2018-07-12 for CONSULT STREP A DIPSTICK 5003 25T IST-501 manufactured by Alere San Diego, Inc.
[114151679]
Investigation conclusion: retention products of lot sta7100031 were tested with 29 strips using 2. 5e07org/ml positive sample. Read time was at 5 minutes. The testing results indicated that all 29 strips showed correct positive results. This lot met qc specifications. The complaint was not replicated with in-house retain product. No false negative results were obtained during in-house testing. The returned product of lot sta7100031 was tested in replicate of 8 strips with 2. 5e07 org/ml positive sample. Read time was at 5 minutes. The testing results indicated that all 8 strips showed correct positive results and all of the results met qc specification. The returned product testing indicated the product performed as expected with 2. 5e07 org/ml positive sample. The customer's observation was not replicated. Manufacturing batch record review did not uncover any abnormalities. A negative result may be obtained if the concentration of the strep a antigen present in the throat swab is not adequate or is below the detectable level of the test. Based on the information available, there is no indication of a product deficiency and no corrective action is required.
Patient Sequence No: 1, Text Type: N, H10
[114151680]
On (b)(6) 2018, the patient presented at the facility with fever, vomiting, abdominal pain, and cough. A consult strep a dipstick test using a dual swab technique produced a negative strep a result. A confirmatory culture was also performed and later produced a positive strep a result (the date of the strep a culture result could not be provided per the customer). On (b)(6) 2018, the patient was prescribed 400 mg of amoxicillin for 10 days based on the confirmatory culture. Per the customer, the patient was delayed in receiving treatment due to the consult strep a dipstick test result. No adverse patient outcome reported. Troubleshooting was conducted with the customer. It was recommended that a single swab method be employed as the swab used for the consult strep a dipstick test may contain antigen below the level of detection for the test.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027969-2018-00088 |
| MDR Report Key | 7684047 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL, |
| Date Received | 2018-07-12 |
| Date of Report | 2018-07-12 |
| Date of Event | 2018-06-01 |
| Date Mfgr Received | 2018-06-13 |
| Date Added to Maude | 2018-07-12 |
| 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 | YA-LING KING |
| Manufacturer Street | 9975 SUMMERS RIDGE ROAD |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8588052084 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONSULT STREP A DIPSTICK 5003 25T |
| Generic Name | STREP A RAPID TEST STRIP |
| Product Code | GTY |
| Date Received | 2018-07-12 |
| Returned To Mfg | 2018-06-21 |
| Model Number | IST-501 |
| Lot Number | STA7100031 |
| Device Expiration Date | 2019-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALERE SAN DIEGO, INC |
| Manufacturer Address | 9975 SUMMERS RIDGE ROAD SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-12 |