MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-03-04 for BECKMAN COULTER ICON 25 HCG FHC-202-BCI manufactured by Innovacon, Inc..
[19170755]
Email from reporter: discrepant (-) urine vs serum quant. First patient drug screen (+): sample drawn in 2008, specific gravity 1. 022 - urine ran in er was (-) at 3 min but "some time after" 3 min was faint (+). Serum quanted at 4600 miu/ml. Second urine sample drawn at 03:40 the next day (no specific gravity available, urine was very dark, migrated very slowly & gave lots of purple background on icon 25) was also icon 25 (-), serum quanted at 4189 miu/ml. Pt quanted both urines & obtained 527 & 215 miu/ml respectively. Has < 1 ml serum & approx 5 ml urine (both draws) in bd urine presevative tubes (boric acid, sodium formate & sodium borate). Second patient (drug screen (+) for acetaminophen but well below levels tested per pi): urine specific gravity 1. 028, icon, 25 (-) at 3 min in er & lab. Serum quanted at 31,628 miu/ml. Has not yet quanted her urine but will do so. Will then freeze all samples & await ship container from pcd.
Patient Sequence No: 1, Text Type: D, B5
[19344700]
Retention device testing performed. Summary of results: the retention devices met qc specification. Correct positive results were obtained when tested with 25miu/ml hcg urine control. Correct positive results were found when tested with 100miu/ml and 10 iu/ml hcg urine control. Clear positive result was observed when tested with 208. 99 iu/ml hcg clinic urine control. Probable root cause: generally, the hcg concentration rises rapidly after pregnancy begins to occur, the level doubled about every 1-2 days. In our study the hcg level in urine always is lower than in serum, so it is possible the urine sample tested (-) with icon 25 hcg but the serum sample obtained high hcg concentration. And because both of them took some drugs, it will have some influence for the test results. Moreover, the urine sample is very likely to be influenced by many factors, such as taking in too much water before testing, which will dilute the urine specimen and decrease the hcg concentration in urine. Conclusion: from our test, all the results were fine. The complaint is not confirmed. Also patient samples were supplied by the customer when running the patients' urine id and serum id, specimen with retention devices, the results were positive at the 3 - minute read time in urine and at the 5 - minute read time in serum. Negative results were noted when testing known negative urine with the retention devices. Manufacturing documentation for this lot number was reviewed. No abnormality had been observed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005689981-2008-00011 |
| MDR Report Key | 1006620 |
| Report Source | 05 |
| Date Received | 2008-03-04 |
| Date of Report | 2008-02-29 |
| Date of Event | 2008-02-11 |
| Date Mfgr Received | 2008-02-14 |
| Date Added to Maude | 2008-05-30 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 4106 SORRENTO VALLEY BLVD. |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8582008910 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BECKMAN COULTER ICON 25 HCG |
| Generic Name | ONE STEP PREGNANCY TEST (URINE/SERUM) |
| Product Code | JHJ |
| Date Received | 2008-03-04 |
| Model Number | FHC-202-BCI |
| Lot Number | HCG7089003 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1005536 |
| Manufacturer | INNOVACON, INC. |
| Manufacturer Address | 4106 SORRENTO VALLEY BLVD. SAN DIEGO CA 92121 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-03-04 |